Trial Outcomes & Findings for Study of Alogliptin Combined With Sulfonylurea in Subjects With Type 2 Diabetes Mellitus. (NCT NCT00286468)
NCT ID: NCT00286468
Last Updated: 2012-02-03
Results Overview
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
500 participants
Primary outcome timeframe
Baseline and Week 26.
Results posted on
2012-02-03
Participant Flow
Participants enrolled at 125 investigative sites in Argentina, Australia, Brazil, Chile, Dominican Republic, Germany, Guatemala, India, Mexico, New Zealand, The Netherlands, Poland, South Africa, Spain, and the United States from 04 April 2006 to 20 June 2007.
Participants with a historical diagnosis of type 2 diabetes mellitus who were inadequately controlled while receiving a stable dose of glyburide monotherapy were enrolled in one of 3, once-daily (QD) treatment groups.
Participant milestones
| Measure |
Placebo
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
99
|
203
|
198
|
|
Overall Study
COMPLETED
|
62
|
153
|
148
|
|
Overall Study
NOT COMPLETED
|
37
|
50
|
50
|
Reasons for withdrawal
| Measure |
Placebo
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Overall Study
Hyperglycemic Rescue
|
28
|
30
|
31
|
|
Overall Study
Adverse Event
|
2
|
6
|
4
|
|
Overall Study
Protocol Violation
|
0
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
8
|
11
|
|
Overall Study
Physician Decision
|
3
|
2
|
1
|
Baseline Characteristics
Study of Alogliptin Combined With Sulfonylurea in Subjects With Type 2 Diabetes Mellitus.
Baseline characteristics by cohort
| Measure |
Placebo
n=99 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=203 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=198 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<65 years
|
72 participants
n=99 Participants
|
153 participants
n=107 Participants
|
145 participants
n=206 Participants
|
370 participants
n=7 Participants
|
|
Age, Customized
Between 65 and 74 years
|
23 participants
n=99 Participants
|
42 participants
n=107 Participants
|
47 participants
n=206 Participants
|
112 participants
n=7 Participants
|
|
Age, Customized
≥75 years
|
4 participants
n=99 Participants
|
8 participants
n=107 Participants
|
6 participants
n=206 Participants
|
18 participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
239 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=99 Participants
|
111 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
261 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 26.Population: Randomized subjects who received at least 1 dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or final visit and glycosylated hemoglobin collected at baseline.
Outcome measures
| Measure |
Placebo
n=201 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=197 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=97 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26.
|
0.01 mg/dL
Standard Error 0.084
|
-0.38 mg/dL
Standard Error 0.058
|
-0.52 mg/dL
Standard Error 0.058
|
SECONDARY outcome
Timeframe: Baseline and Week 4.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at week 4 due to unavailable prior value to carry forward.
The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and Glycosylated Hemoglobin collected at baseline.
Outcome measures
| Measure |
Placebo
n=89 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=191 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=186 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 4).
|
-0.18 mg/dL
Standard Error 0.042
|
-0.40 mg/dL
Standard Error 0.028
|
-0.46 mg/dL
Standard Error 0.029
|
SECONDARY outcome
Timeframe: Baseline and Week 8.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and Glycosylated Hemoglobin collected at baseline.
Outcome measures
| Measure |
Placebo
n=97 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=201 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=197 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 8).
|
-0.18 mg/dL
Standard Error 0.057
|
-0.57 mg/dL
Standard Error 0.040
|
-0.65 mg/dL
Standard Error 0.040
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and Glycosylated Hemoglobin collected at baseline.
Outcome measures
| Measure |
Placebo
n=97 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=201 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=197 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 12).
|
-0.17 mg/dL
Standard Error 0.068
|
-0.58 mg/dL
Standard Error 0.047
|
-0.69 mg/dL
Standard Error 0.047
|
SECONDARY outcome
Timeframe: Baseline and Week 16.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and Glycosylated Hemoglobin collected at baseline.
Outcome measures
| Measure |
Placebo
n=97 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=201 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=197 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 16).
|
-0.16 mg/dL
Standard Error 0.072
|
-0.53 mg/dL
Standard Error 0.050
|
-0.66 mg/dL
Standard Error 0.051
|
SECONDARY outcome
Timeframe: Baseline and Week 20.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change in the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and Glycosylated Hemoglobin collected at baseline.
Outcome measures
| Measure |
Placebo
n=97 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=201 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=197 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (Week 20).
|
-0.08 mg/dL
Standard Error 0.077
|
-0.43 mg/dL
Standard Error 0.053
|
-0.60 mg/dL
Standard Error 0.054
|
SECONDARY outcome
Timeframe: Baseline and Week 1.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.
The change between the value of fasting plasma glucose collected at final visit or week 1 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Placebo
n=91 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=189 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=185 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 1).
|
0.3 mg/dL
Standard Error 3.62
|
-11.8 mg/dL
Standard Error 2.51
|
-19.0 mg/dL
Standard Error 2.53
|
SECONDARY outcome
Timeframe: Baseline and Week 2.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.
The change between the value of fasting plasma glucose collected at week 2 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Placebo
n=95 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=197 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=194 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 2).
|
-1.8 mg/dL
Standard Error 3.20
|
-16.7 mg/dL
Standard Error 2.21
|
-21.8 mg/dL
Standard Error 2.23
|
SECONDARY outcome
Timeframe: Baseline and Week 4.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.
The change between the value of fasting plasma glucose collected at week 4 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Placebo
n=97 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=198 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=197 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 4).
|
-3.7 mg/dL
Standard Error 3.48
|
-14.6 mg/dL
Standard Error 2.42
|
-21.1 mg/dL
Standard Error 2.43
|
SECONDARY outcome
Timeframe: Baseline and Week 8.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Placebo
n=97 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=200 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=198 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 8).
|
-3.2 mg/dL
Standard Error 3.55
|
-19.9 mg/dL
Standard Error 2.46
|
-18.6 mg/dL
Standard Error 2.47
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Placebo
n=98 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=201 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=198 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 12).
|
-3.4 mg/dL
Standard Error 3.79
|
-13.5 mg/dL
Standard Error 2.64
|
-15.0 mg/dL
Standard Error 2.66
|
SECONDARY outcome
Timeframe: Baseline and Week 16.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Placebo
n=99 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=201 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=198 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 16).
|
-7.1 mg/dL
Standard Error 4.03
|
-9.0 mg/dL
Standard Error 2.81
|
-13.0 mg/dL
Standard Error 2.83
|
SECONDARY outcome
Timeframe: Baseline and Week 20.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Placebo
n=99 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=201 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=198 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 20).
|
-0.4 mg/dL
Standard Error 4.41
|
-9.3 mg/dL
Standard Error 3.08
|
-13.6 mg/dL
Standard Error 3.10
|
SECONDARY outcome
Timeframe: Baseline and Week 26.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between the value of fasting plasma glucose collected at week 26 or final visit and fasting plasma glucose collected at baseline.
Outcome measures
| Measure |
Placebo
n=99 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=201 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=198 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (Week 26).
|
2.2 mg/dL
Standard Error 4.77
|
-4.7 mg/dL
Standard Error 3.33
|
-8.4 mg/dL
Standard Error 3.36
|
SECONDARY outcome
Timeframe: 26 Weeks.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set) and have at least 1 post-baseline measurement for fasting plasma glucose.
The number of participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during the 26 week study.
Outcome measures
| Measure |
Placebo
n=99 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=200 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=198 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Number of Participants With Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg Per dL).
|
53 participants
|
94 participants
|
79 participants
|
SECONDARY outcome
Timeframe: 26 Weeks.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set).
The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 26 week study.
Outcome measures
| Measure |
Placebo
n=99 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=201 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=198 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Number of Participants Requiring Rescue.
|
28 participants
|
30 participants
|
31 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward
The change between the value of fasting proinsulin collected at week 4 and fasting proinsulin collected at baseline.
Outcome measures
| Measure |
Placebo
n=85 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=178 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=178 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Proinsulin (Week 4).
|
-3.0 pmol/L
Standard Error 2.68
|
-2.6 pmol/L
Standard Error 1.84
|
0.7 pmol/L
Standard Error 1.84
|
SECONDARY outcome
Timeframe: Baseline and Week 8.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward
The change between the value of fasting proinsulin collected at week 8 and fasting proinsulin collected at baseline.
Outcome measures
| Measure |
Placebo
n=91 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=187 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=188 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Proinsulin (Week 8).
|
-4.2 pmol/L
Standard Error 2.61
|
-4.5 pmol/L
Standard Error 1.81
|
-0.9 pmol/L
Standard Error 1.81
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between the value of fasting proinsulin collected at week 12 and fasting proinsulin collected at baseline.
Outcome measures
| Measure |
Placebo
n=91 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=188 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=188 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Proinsulin (Week 12).
|
-0.5 pmol/L
Standard Error 2.49
|
-0.7 pmol/L
Standard Error 1.73
|
-0.7 pmol/L
Standard Error 1.73
|
SECONDARY outcome
Timeframe: Baseline and Week 16.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between the value of fasting proinsulin collected at week 16 and fasting proinsulin collected at baseline.
Outcome measures
| Measure |
Placebo
n=91 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=188 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=188 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Proinsulin (Week 16).
|
-1.8 pmol/L
Standard Error 2.61
|
-1.5 pmol/L
Standard Error 1.81
|
-1.1 pmol/L
Standard Error 1.81
|
SECONDARY outcome
Timeframe: Baseline and Week 20.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between the value of fasting proinsulin collected at week 20 and fasting proinsulin collected at baseline.
Outcome measures
| Measure |
Placebo
n=91 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=188 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=188 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Proinsulin (Week 20).
|
-2.5 pmol/L
Standard Error 2.65
|
-2.1 pmol/L
Standard Error 1.84
|
0.0 pmol/L
Standard Error 1.84
|
SECONDARY outcome
Timeframe: Baseline and Week 26.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between the value of fasting proinsulin collected at week 26 or final visit and fasting proinsulin collected at baseline.
Outcome measures
| Measure |
Placebo
n=91 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=188 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=188 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Proinsulin (Week 26).
|
-2.0 pmol/L
Standard Error 2.60
|
-3.9 pmol/L
Standard Error 1.81
|
-2.1 pmol/L
Standard Error 1.81
|
SECONDARY outcome
Timeframe: Baseline and Week 4.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward
The change between the value of insulin collected at week 4 and insulin collected at baseline.
Outcome measures
| Measure |
Placebo
n=83 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=173 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=174 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Insulin (Week 4).
|
-0.62 mcIU/mL
Standard Error 1.273
|
0.64 mcIU/mL
Standard Error 0.879
|
0.89 mcIU/mL
Standard Error 0.877
|
SECONDARY outcome
Timeframe: Baseline and Week 8.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward
The change between the value of insulin collected at week 8 and insulin collected at baseline.
Outcome measures
| Measure |
Placebo
n=89 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=185 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=185 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Insulin (Week 8).
|
-0.81 mcIU/mL
Standard Error 1.114
|
-0.62 mcIU/mL
Standard Error 0.770
|
0.38 mcIU/mL
Standard Error 0.771
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between the value of insulin collected at week 12 and insulin collected at baseline.
Outcome measures
| Measure |
Placebo
n=89 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=186 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=186 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Insulin (Week 12).
|
-0.02 mcIU/mL
Standard Error 1.464
|
1.33 mcIU/mL
Standard Error 1.009
|
1.00 mcIU/mL
Standard Error 1.010
|
SECONDARY outcome
Timeframe: Baseline and Week 16.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between the value of insulin collected at week 16 and insulin collected at baseline.
Outcome measures
| Measure |
Placebo
n=89 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=186 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=186 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Insulin (Week 16).
|
-1.21 mcIU/mL
Standard Error 1.368
|
1.74 mcIU/mL
Standard Error 0.943
|
0.51 mcIU/mL
Standard Error 0.944
|
SECONDARY outcome
Timeframe: Baseline and Week 20.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between the value of insulin collected at week 20 and insulin collected at baseline.
Outcome measures
| Measure |
Placebo
n=89 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=186 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=186 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Insulin (Week 20).
|
-0.07 mcIU/mL
Standard Error 1.393
|
1.18 mcIU/mL
Standard Error 0.960
|
0.93 mcIU/mL
Standard Error 0.962
|
SECONDARY outcome
Timeframe: Baseline and Week 26.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between the value of insulin collected at week 26 and insulin collected at baseline.
Outcome measures
| Measure |
Placebo
n=89 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=186 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=186 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Insulin (Week 26).
|
-1.89 mcIU/mL
Standard Error 1.081
|
-0.85 mcIU/mL
Standard Error 0.745
|
0.14 mcIU/mL
Standard Error 0.746
|
SECONDARY outcome
Timeframe: Baseline and Week 4.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward
The change between the ratio value of proinsulin and insulin collected at week 4 and the ratio value of proinsulin and insulin collected at baseline.
Outcome measures
| Measure |
Placebo
n=83 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=172 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=174 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Proinsulin/Insulin Ratio (Week 4).
|
-0.008 ratio
Standard Error 0.0180
|
-0.064 ratio
Standard Error 0.0125
|
-0.043 ratio
Standard Error 0.0124
|
SECONDARY outcome
Timeframe: Baseline and Week 8.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward
The change between the ratio value of proinsulin and insulin collected at week 8 and the ratio value of proinsulin and insulin collected at baseline.
Outcome measures
| Measure |
Placebo
n=89 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=184 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=185 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Proinsulin/Insulin Ratio (Week 8).
|
-0.009 ratio
Standard Error 0.0158
|
-0.052 ratio
Standard Error 0.0110
|
-0.045 ratio
Standard Error 0.0109
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between the ratio value of proinsulin and insulin collected at week 12 and the ratio value of proinsulin and insulin collected at baseline.
Outcome measures
| Measure |
Placebo
n=89 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=185 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=186 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Proinsulin/Insulin Ratio (Week 12).
|
-0.002 ratio
Standard Error 0.0163
|
-0.030 ratio
Standard Error 0.0113
|
-0.040 ratio
Standard Error 0.0113
|
SECONDARY outcome
Timeframe: Baseline and Week 16.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between the ratio value of proinsulin and insulin collected at week 16 and the ratio value of proinsulin and insulin collected at baseline.
Outcome measures
| Measure |
Placebo
n=89 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=185 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=186 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Proinsulin/Insulin Ratio (Week 16).
|
0.003 ratio
Standard Error 0.0172
|
-0.037 ratio
Standard Error 0.0119
|
-0.041 ratio
Standard Error 0.0119
|
SECONDARY outcome
Timeframe: Baseline and Week 20.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between the ratio value of proinsulin and insulin collected at week 20 and the ratio value of proinsulin and insulin collected at baseline.
Outcome measures
| Measure |
Placebo
n=89 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=185 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=186 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Proinsulin/Insulin Ratio (Week 20).
|
-0.005 ratio
Standard Error 0.0167
|
-0.035 ratio
Standard Error 0.0116
|
-0.036 ratio
Standard Error 0.0115
|
SECONDARY outcome
Timeframe: Baseline and Week 26.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between the ratio value of proinsulin and insulin collected at week 26 or final visit and the ratio value of proinsulin and insulin collected at baseline.
Outcome measures
| Measure |
Placebo
n=89 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=185 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=186 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Proinsulin/Insulin Ratio (Week 26).
|
-0.008 ratio
Standard Error 0.0161
|
-0.034 ratio
Standard Error 0.0111
|
-0.034 ratio
Standard Error 0.0111
|
SECONDARY outcome
Timeframe: Baseline and Week 4.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.
The change between the value of C-peptide collected at week 4 and C-peptide collected at baseline.
Outcome measures
| Measure |
Placebo
n=87 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=183 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=184 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in C-peptide (Week 4).
|
-0.041 ng/mL
Standard Error 0.1355
|
0.122 ng/mL
Standard Error 0.0932
|
0.136 ng/mL
Standard Error 0.0930
|
SECONDARY outcome
Timeframe: Baseline and Week 8.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF). Smaller "n" at earlier timepoints due to unavailable prior values to carry forward.
The change between the value of C-peptide collected at week 8 and C-peptide collected at baseline.
Outcome measures
| Measure |
Placebo
n=94 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=196 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=196 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in C-peptide (Week 8).
|
-0.176 ng/mL
Standard Error 0.1138
|
0.092 ng/mL
Standard Error 0.0786
|
0.173 ng/mL
Standard Error 0.0785
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline.
Outcome measures
| Measure |
Placebo
n=95 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=198 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=196 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in C-peptide (Week 12).
|
-0.020 ng/mL
Standard Error 0.1155
|
0.162 ng/mL
Standard Error 0.0797
|
0.206 ng/mL
Standard Error 0.0801
|
SECONDARY outcome
Timeframe: Baseline and Week 16.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between the value of C-peptide collected at week 16 and C-peptide collected at baseline.
Outcome measures
| Measure |
Placebo
n=96 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=198 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=196 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in C-peptide (Week 16).
|
-0.007 ng/mL
Standard Error 0.1206
|
0.222 ng/mL
Standard Error 0.0837
|
0.153 ng/mL
Standard Error 0.0841
|
SECONDARY outcome
Timeframe: Baseline and Week 20.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between the value of C-peptide collected at week 20 and C-peptide collected at baseline.
Outcome measures
| Measure |
Placebo
n=96 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=198 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=196 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in C-peptide (Week 20).
|
-0.016 ng/mL
Standard Error 0.1275
|
-0.001 ng/mL
Standard Error 0.0884
|
0.122 ng/mL
Standard Error 0.0889
|
SECONDARY outcome
Timeframe: Baseline and Week 26.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between the value of C-peptide collected at week 26 or final visit and C-peptide collected at baseline.
Outcome measures
| Measure |
Placebo
n=96 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=198 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=196 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in C-peptide (Week 26).
|
-0.215 ng/mL
Standard Error 0.1326
|
-0.140 ng/mL
Standard Error 0.0920
|
-0.153 ng/mL
Standard Error 0.0925
|
SECONDARY outcome
Timeframe: Baseline and Week 26.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set).
The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5% during the 26 week study.
Outcome measures
| Measure |
Placebo
n=99 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=203 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=198 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Number of Participants With Glycosylated Hemoglobin ≤ 6.5%.
|
7 participants
|
19 participants
|
28 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 26.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set).
The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.0% during the 26 week study.
Outcome measures
| Measure |
Placebo
n=99 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=203 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=198 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Number of Participants With Glycosylated Hemoglobin ≤ 7.0%.
|
18 participants
|
60 participants
|
69 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 26.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set).
The number of participants with a value for the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) less than or equal to 7.5% during the 26 week study.
Outcome measures
| Measure |
Placebo
n=99 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=203 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=198 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Number of Participants With Glycosylated Hemoglobin ≤ 7.5%.
|
33 participants
|
94 participants
|
112 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 26.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set).
The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5% during the 26 week study.
Outcome measures
| Measure |
Placebo
n=99 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=203 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=198 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 0.5%.
|
26 participants
|
96 participants
|
100 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 26.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set).
The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.0% during the 26 week study.
Outcome measures
| Measure |
Placebo
n=99 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=203 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=198 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.0%.
|
13 participants
|
38 participants
|
59 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 26.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set).
The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 1.5% during the 26 week study.
Outcome measures
| Measure |
Placebo
n=99 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=203 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=198 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 1.5%.
|
7 participants
|
13 participants
|
24 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 26.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set).
The number of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 2.0% during the 26 week study.
Outcome measures
| Measure |
Placebo
n=99 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=203 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=198 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Number of Participants With Glycosylated Hemoglobin Decrease From Baseline ≥ 2.0%.
|
4 participants
|
5 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Baseline and Week 8.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between Body Weight measured at week 8 and Body Weight measured at baseline.
Outcome measures
| Measure |
Placebo
n=95 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=194 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=188 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Body Weight (Week 8).
|
-0.27 kg
Standard Error 0.175
|
0.47 kg
Standard Error 0.122
|
0.33 kg
Standard Error 0.124
|
SECONDARY outcome
Timeframe: Baseline and Week 12.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between Body Weight measured at week 12 and Body Weight measured at baseline.
Outcome measures
| Measure |
Placebo
n=96 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=197 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=194 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Body Weight (Week 12).
|
-0.12 kg
Standard Error 0.204
|
0.58 kg
Standard Error 0.142
|
0.40 kg
Standard Error 0.143
|
SECONDARY outcome
Timeframe: Baseline and Week 20.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between Body Weight measured at week 20 and Body Weight measured at baseline.
Outcome measures
| Measure |
Placebo
n=96 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=197 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=195 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Body Weight (Week 20).
|
-0.30 kg
Standard Error 0.264
|
0.79 kg
Standard Error 0.184
|
0.61 kg
Standard Error 0.185
|
SECONDARY outcome
Timeframe: Baseline and Week 26.Population: Randomized participants who received at least one dose of study drug (Full Analysis Set), and who had measurements at baseline and at the visit. Missing data are imputed using last observation carried forward (LOCF).
The change between Body Weight measured at week 26 or final visit and Body Weight measured at baseline.
Outcome measures
| Measure |
Placebo
n=96 Participants
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=197 Participants
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=195 Participants
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Change From Baseline in Body Weight (Week 26).
|
-0.20 kg
Standard Error 0.277
|
0.60 kg
Standard Error 0.193
|
0.68 kg
Standard Error 0.194
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Alogliptin 12.5 mg QD
Serious events: 11 serious events
Other events: 49 other events
Deaths: 0 deaths
Alogliptin 25 mg QD
Serious events: 11 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=99 participants at risk
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=203 participants at risk
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=198 participants at risk
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
2/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.49%
1/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.49%
1/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.49%
1/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.51%
1/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.49%
1/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
1.0%
1/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cellulitis
|
1.0%
1/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.49%
1/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.51%
1/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.49%
1/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Osteomyelitis acute
|
1.0%
1/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.51%
1/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.51%
1/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.51%
1/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
electrocardiogram change
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.49%
1/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.49%
1/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.49%
1/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.49%
1/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.51%
1/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.51%
1/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Facial palsy
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.51%
1/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.49%
1/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.51%
1/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.51%
1/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Placebo
n=99 participants at risk
Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 12.5 mg QD
n=203 participants at risk
Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
Alogliptin 25 mg QD
n=198 participants at risk
Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
6/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.0%
4/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.5%
5/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
3.0%
3/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.5%
5/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
11/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
2.0%
2/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.4%
7/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.6%
11/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
3.0%
3/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.4%
9/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.1%
10/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
3/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.0%
4/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.5%
9/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.9%
8/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.5%
9/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.0%
2/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.9%
8/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.0%
8/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Influenza
|
4.0%
4/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.0%
4/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.5%
5/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
2/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.9%
8/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.0%
8/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/99 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.0%
4/203 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.5%
7/198 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days (or 30 days for a serious adverse event) after the last dose of double-blind study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Sr. VP, Clinical Science
Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER