Trial Outcomes & Findings for Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Biguanides (NCT NCT01964976)
NCT ID: NCT01964976
Last Updated: 2017-04-13
Results Overview
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + biguanides and alogliptin + other arm separately.
Recruitment status
COMPLETED
Target enrollment
1096 participants
Primary outcome timeframe
Baseline up to 12 months
Results posted on
2017-04-13
Participant Flow
Participants took part in the study at 207 investigative sites in Japan from 01 July 2011 to 31 December 2014.
Participants with type 2 diabetes mellitus started treatment with alogliptin as per routine clinical practice were observed. As per protocol, participants were enrolled in 1 observational group at the start and were divided into 2 groups based on biguanide use for analysis of safety endpoints. Participant flow data was collected for overall arm.
Participant milestones
| Measure |
All Population
All participants who received alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months along with biguanide or without biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
|---|---|
|
Overall Study
STARTED
|
1096
|
|
Overall Study
COMPLETED
|
1065
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
All Population
All participants who received alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months along with biguanide or without biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
|---|---|
|
Overall Study
Protocol Violation
|
31
|
Baseline Characteristics
Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Biguanides
Baseline characteristics by cohort
| Measure |
Alogliptin + Biguanides
n=954 Participants
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
Alogliptin + Other
n=109 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
Total
n=1063 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Less than (<) 65 years
|
539 participants
n=99 Participants
|
68 participants
n=107 Participants
|
607 participants
n=206 Participants
|
|
Age, Customized
Greater than or equal to (>=) 65 years
|
415 participants
n=99 Participants
|
41 participants
n=107 Participants
|
456 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
388 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
425 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
566 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
638 Participants
n=206 Participants
|
|
Time from Diagnosis of Type 2 Diabetes
<2 years
|
114 participants
n=99 Participants
|
16 participants
n=107 Participants
|
130 participants
n=206 Participants
|
|
Time from Diagnosis of Type 2 Diabetes
>=2 to <5 years
|
169 participants
n=99 Participants
|
20 participants
n=107 Participants
|
189 participants
n=206 Participants
|
|
Time from Diagnosis of Type 2 Diabetes
>=5 to <10 years
|
218 participants
n=99 Participants
|
19 participants
n=107 Participants
|
237 participants
n=206 Participants
|
|
Time from Diagnosis of Type 2 Diabetes
>=10 years
|
254 participants
n=99 Participants
|
27 participants
n=107 Participants
|
281 participants
n=206 Participants
|
|
Time from Diagnosis of Type 2 Diabetes
Unknown
|
199 participants
n=99 Participants
|
27 participants
n=107 Participants
|
226 participants
n=206 Participants
|
|
Body Mass Index
<25 kilogram per square meter (kg/m^2)
|
345 participants
n=99 Participants
|
35 participants
n=107 Participants
|
380 participants
n=206 Participants
|
|
Body Mass Index
>=25 kg/m^2
|
410 participants
n=99 Participants
|
45 participants
n=107 Participants
|
455 participants
n=206 Participants
|
|
Body Mass Index
Unknown
|
199 participants
n=99 Participants
|
29 participants
n=107 Participants
|
228 participants
n=206 Participants
|
|
Waist Circumference
<85 centimeter (cm) (Male)
|
25 participants
n=99 Participants
|
5 participants
n=107 Participants
|
30 participants
n=206 Participants
|
|
Waist Circumference
>=85 cm (Male)
|
90 participants
n=99 Participants
|
4 participants
n=107 Participants
|
94 participants
n=206 Participants
|
|
Waist Circumference
Unknown (Male)
|
451 participants
n=99 Participants
|
63 participants
n=107 Participants
|
514 participants
n=206 Participants
|
|
Waist Circumference
<90 cm (Female)
|
37 participants
n=99 Participants
|
4 participants
n=107 Participants
|
41 participants
n=206 Participants
|
|
Waist Circumference
>=90 cm (Female)
|
33 participants
n=99 Participants
|
3 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Waist Circumference
Unknown (Female)
|
318 participants
n=99 Participants
|
30 participants
n=107 Participants
|
348 participants
n=206 Participants
|
|
Pregnancy Status
Not pregnant
|
388 participants
n=99 Participants
|
37 participants
n=107 Participants
|
425 participants
n=206 Participants
|
|
Pregnancy Status
Pregnant
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Healthcare Category
Outpatient
|
920 participants
n=99 Participants
|
102 participants
n=107 Participants
|
1022 participants
n=206 Participants
|
|
Healthcare Category
Inpatient
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Healthcare Category
Outpatient and inpatient
|
32 participants
n=99 Participants
|
6 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Degree of Renal Dysfunction
Normal
|
213 participants
n=99 Participants
|
12 participants
n=107 Participants
|
225 participants
n=206 Participants
|
|
Degree of Renal Dysfunction
Mild
|
359 participants
n=99 Participants
|
50 participants
n=107 Participants
|
409 participants
n=206 Participants
|
|
Degree of Renal Dysfunction
Moderate
|
135 participants
n=99 Participants
|
13 participants
n=107 Participants
|
148 participants
n=206 Participants
|
|
Degree of Renal Dysfunction
Severe
|
3 participants
n=99 Participants
|
0 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Degree of Renal Dysfunction
Unknown
|
244 participants
n=99 Participants
|
34 participants
n=107 Participants
|
278 participants
n=206 Participants
|
|
History of Allergy
Had allergy
|
773 participants
n=99 Participants
|
84 participants
n=107 Participants
|
857 participants
n=206 Participants
|
|
History of Allergy
Did not have allergy
|
92 participants
n=99 Participants
|
10 participants
n=107 Participants
|
102 participants
n=206 Participants
|
|
History of Allergy
Unknown
|
89 participants
n=99 Participants
|
15 participants
n=107 Participants
|
104 participants
n=206 Participants
|
|
Health-related Complications
Had complications
|
862 participants
n=99 Participants
|
91 participants
n=107 Participants
|
953 participants
n=206 Participants
|
|
Health-related Complications
Had no complications
|
92 participants
n=99 Participants
|
18 participants
n=107 Participants
|
110 participants
n=206 Participants
|
|
Diabetic complications
Had complications
|
206 participants
n=99 Participants
|
20 participants
n=107 Participants
|
226 participants
n=206 Participants
|
|
Diabetic complications
Had No Complications
|
748 participants
n=99 Participants
|
89 participants
n=107 Participants
|
837 participants
n=206 Participants
|
|
Breakdown of diabetic complications
Diabetic nephropathy
|
110 participants
n=99 Participants
|
12 participants
n=107 Participants
|
122 participants
n=206 Participants
|
|
Breakdown of diabetic complications
Diabetic retinopathy
|
91 participants
n=99 Participants
|
10 participants
n=107 Participants
|
101 participants
n=206 Participants
|
|
Breakdown of diabetic complications
Diabetic neuropathy
|
83 participants
n=99 Participants
|
8 participants
n=107 Participants
|
91 participants
n=206 Participants
|
|
Complications of Hypertension
Had complications
|
567 participants
n=99 Participants
|
54 participants
n=107 Participants
|
621 participants
n=206 Participants
|
|
Complications of Hypertension
Had no complications
|
387 participants
n=99 Participants
|
55 participants
n=107 Participants
|
442 participants
n=206 Participants
|
|
Complications of Dyslipidemia
Had complications
|
623 participants
n=99 Participants
|
69 participants
n=107 Participants
|
692 participants
n=206 Participants
|
|
Complications of Dyslipidemia
Had no complications
|
331 participants
n=99 Participants
|
40 participants
n=107 Participants
|
371 participants
n=206 Participants
|
|
Complications of Hyperuricemia
Had complications
|
69 participants
n=99 Participants
|
14 participants
n=107 Participants
|
83 participants
n=206 Participants
|
|
Complications of Hyperuricemia
Had no complications
|
885 participants
n=99 Participants
|
95 participants
n=107 Participants
|
980 participants
n=206 Participants
|
|
Complications of Liver Damage
Had complications
|
203 participants
n=99 Participants
|
20 participants
n=107 Participants
|
223 participants
n=206 Participants
|
|
Complications of Liver Damage
Had no complications
|
751 participants
n=99 Participants
|
89 participants
n=107 Participants
|
840 participants
n=206 Participants
|
|
Breakdown of Complications of Liver Damage
Hepatic steatosis
|
158 participants
n=99 Participants
|
15 participants
n=107 Participants
|
173 participants
n=206 Participants
|
|
Breakdown of Complications of Liver Damage
Hepatitis alcoholic
|
23 participants
n=99 Participants
|
5 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Breakdown of Complications of Liver Damage
Chronic hepatitis
|
15 participants
n=99 Participants
|
5 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Breakdown of Complications of Liver Damage
Hepatic cirrhosis
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Breakdown of Complications of Liver Damage
Other
|
7 participants
n=99 Participants
|
0 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Degree of Hepatic Dysfunction
Normal
|
597 participants
n=99 Participants
|
65 participants
n=107 Participants
|
662 participants
n=206 Participants
|
|
Degree of Hepatic Dysfunction
Grade 1
|
81 participants
n=99 Participants
|
13 participants
n=107 Participants
|
94 participants
n=206 Participants
|
|
Degree of Hepatic Dysfunction
Grade 2
|
21 participants
n=99 Participants
|
1 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Degree of Hepatic Dysfunction
Unknown
|
255 participants
n=99 Participants
|
30 participants
n=107 Participants
|
285 participants
n=206 Participants
|
|
Complications of Renal Damage
Had complications
|
114 participants
n=99 Participants
|
12 participants
n=107 Participants
|
126 participants
n=206 Participants
|
|
Complications of Renal Damage
Had No Complications
|
840 participants
n=99 Participants
|
97 participants
n=107 Participants
|
937 participants
n=206 Participants
|
|
Breakdown of Complications of Renal Damage
Nephrotic syndrome
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Breakdown of Complications of Renal Damage
Glomerulonephritis
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Breakdown of Complications of Renal Damage
Renal failure chronic
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Breakdown of Complications of Renal Damage
Other
|
110 participants
n=99 Participants
|
12 participants
n=107 Participants
|
122 participants
n=206 Participants
|
|
Complications of Heart Disease
Had complications
|
103 participants
n=99 Participants
|
7 participants
n=107 Participants
|
110 participants
n=206 Participants
|
|
Complications of Heart Disease
Had no complications
|
851 participants
n=99 Participants
|
102 participants
n=107 Participants
|
953 participants
n=206 Participants
|
|
Breakdown of Complications of Heart Disease
Cardiac failure
|
19 participants
n=99 Participants
|
1 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Breakdown of Complications of Heart Disease
Myocardial infarction
|
24 participants
n=99 Participants
|
1 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Breakdown of Complications of Heart Disease
Angina pectoris
|
49 participants
n=99 Participants
|
3 participants
n=107 Participants
|
52 participants
n=206 Participants
|
|
Breakdown of Complications of Heart Disease
Other
|
24 participants
n=99 Participants
|
2 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Complications of Heart Failure
Had complications
|
19 participants
n=99 Participants
|
1 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Complications of Heart Failure
Had no complications
|
935 participants
n=99 Participants
|
108 participants
n=107 Participants
|
1043 participants
n=206 Participants
|
|
New York Heart Association (NYHA) Heart Failure Classification
NYHA Class I
|
13 participants
n=99 Participants
|
0 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
New York Heart Association (NYHA) Heart Failure Classification
NYHA Class II
|
5 participants
n=99 Participants
|
0 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
New York Heart Association (NYHA) Heart Failure Classification
NYHA Class IV
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Complications of Stroke-related Disease
Had complications
|
58 participants
n=99 Participants
|
5 participants
n=107 Participants
|
63 participants
n=206 Participants
|
|
Complications of Stroke-related Disease
Had no complications
|
896 participants
n=99 Participants
|
104 participants
n=107 Participants
|
1000 participants
n=206 Participants
|
|
Breakdown of Complications of Stroke-related Disease
Cerebral infarction
|
57 participants
n=99 Participants
|
5 participants
n=107 Participants
|
62 participants
n=206 Participants
|
|
Breakdown of Complications of Stroke-related Disease
Cerebral hemorrhage
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Complications of Allergic Disease
Had complications
|
66 participants
n=99 Participants
|
7 participants
n=107 Participants
|
73 participants
n=206 Participants
|
|
Complications of Allergic Disease
Had no complications
|
888 participants
n=99 Participants
|
102 participants
n=107 Participants
|
990 participants
n=206 Participants
|
|
Complications of Malignant Tumor
Had complications
|
18 participants
n=99 Participants
|
6 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Complications of Malignant Tumor
Had no complications
|
936 participants
n=99 Participants
|
103 participants
n=107 Participants
|
1039 participants
n=206 Participants
|
|
Other Complications
Had complications
|
315 participants
n=99 Participants
|
38 participants
n=107 Participants
|
353 participants
n=206 Participants
|
|
Other Complications
Had no complications
|
639 participants
n=99 Participants
|
71 participants
n=107 Participants
|
710 participants
n=206 Participants
|
|
Presence of Medical History
Had medical history
|
150 participants
n=99 Participants
|
30 participants
n=107 Participants
|
180 participants
n=206 Participants
|
|
Presence of Medical History
Did not have medical history
|
694 participants
n=99 Participants
|
68 participants
n=107 Participants
|
762 participants
n=206 Participants
|
|
Presence of Medical History
Unknown
|
110 participants
n=99 Participants
|
11 participants
n=107 Participants
|
121 participants
n=206 Participants
|
|
History of Alcohol Consumption
Yes
|
231 participants
n=99 Participants
|
26 participants
n=107 Participants
|
257 participants
n=206 Participants
|
|
History of Alcohol Consumption
No
|
573 participants
n=99 Participants
|
60 participants
n=107 Participants
|
633 participants
n=206 Participants
|
|
History of Alcohol Consumption
Unknown
|
150 participants
n=99 Participants
|
23 participants
n=107 Participants
|
173 participants
n=206 Participants
|
|
Smoking Classification
Never Smoked
|
442 participants
n=99 Participants
|
45 participants
n=107 Participants
|
487 participants
n=206 Participants
|
|
Smoking Classification
Current Smoker
|
167 participants
n=99 Participants
|
18 participants
n=107 Participants
|
185 participants
n=206 Participants
|
|
Smoking Classification
Ex-smoker
|
162 participants
n=99 Participants
|
15 participants
n=107 Participants
|
177 participants
n=206 Participants
|
|
Smoking Classification
Unknown
|
183 participants
n=99 Participants
|
31 participants
n=107 Participants
|
214 participants
n=206 Participants
|
|
Glycosylated Hemoglobin (HbA1c) Level
HbA1c <6.0 percent (%)
|
12 participants
n=99 Participants
|
5 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Glycosylated Hemoglobin (HbA1c) Level
HbA1c >=6.0% to <7.0%
|
177 participants
n=99 Participants
|
16 participants
n=107 Participants
|
193 participants
n=206 Participants
|
|
Glycosylated Hemoglobin (HbA1c) Level
HbA1c >=7.0% to <8.0%
|
381 participants
n=99 Participants
|
43 participants
n=107 Participants
|
424 participants
n=206 Participants
|
|
Glycosylated Hemoglobin (HbA1c) Level
HbA1c >=8.0%
|
341 participants
n=99 Participants
|
35 participants
n=107 Participants
|
376 participants
n=206 Participants
|
|
Glycosylated Hemoglobin (HbA1c) Level
Unknown
|
43 participants
n=99 Participants
|
10 participants
n=107 Participants
|
53 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 12 monthsPopulation: The safety analysis set was defined as all participants who completed the study and had safety data available.
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + biguanides and alogliptin + other arm separately.
Outcome measures
| Measure |
Alogliptin + Biguanides
n=954 Participants
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
Alogliptin + Other
n=109 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
|---|---|---|
|
Number of Participants Reporting One or More Adverse Drug Reactions
|
26 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Baseline up to 12 monthsPopulation: The safety analysis set was defined as all participants who completed the study and had safety data available.
Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + biguanides and alogliptin + other arm separately.
Outcome measures
| Measure |
Alogliptin + Biguanides
n=954 Participants
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
Alogliptin + Other
n=109 Participants
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
|---|---|---|
|
Number of Participants Reporting One or More Serious Adverse Drug Reactions
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
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 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.
Outcome measures
| Measure |
Alogliptin + Biguanides
n=880 Participants
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Baseline (n = 880)
|
7.84 percentage of glycosylated hemoglobin
Standard Deviation 1.215
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Month 1 (n = 671)
|
-0.35 percentage of glycosylated hemoglobin
Standard Deviation 0.630
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Month 3 (n = 768)
|
-0.59 percentage of glycosylated hemoglobin
Standard Deviation 0.943
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Month 6 (n = 776)
|
-0.62 percentage of glycosylated hemoglobin
Standard Deviation 1.011
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Month 12 (n = 723)
|
-0.65 percentage of glycosylated hemoglobin
Standard Deviation 1.027
|
—
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change at Final Assessment (n = 880)
|
-0.58 percentage of glycosylated hemoglobin
Standard Deviation 1.066
|
—
|
SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 12)Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.
The rate of achieving objective glycemic control in HbA1c level, was calculated at 12 month or final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as \<8.0%, \<7.0%, and \<6.0% of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.
Outcome measures
| Measure |
Alogliptin + Biguanides
n=880 Participants
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
|---|---|---|
|
Percentage of Participants of Achieving Objective Glycemic Control
<8.0% (Baseline)
|
62.8 percentage of participants
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<8.0% (Final assessment [upto month 12])
|
80.5 percentage of participants
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<7.0% (Baseline)
|
21.4 percentage of participants
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<7.0% (Final assessment [upto month 12])
|
47.2 percentage of participants
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<6.0% (Baseline)
|
1.4 percentage of participants
|
—
|
|
Percentage of Participants of Achieving Objective Glycemic Control
<6.0% (Final assessment [upto month 12])
|
5.2 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)Population: The efficacy assessment population was defined as participants who completed the study and had fasting blood glucose data at baseline and post-baseline time points available.
The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the biguanide treatment.
Outcome measures
| Measure |
Alogliptin + Biguanides
n=253 Participants
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
|---|---|---|
|
Change From Baseline in Fasting Blood Glucose
Change at Month 6 (n = 189)
|
-16.0 milligram per deciliter (mg/dL)
Standard Deviation 44.03
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at Month 12 (n = 186)
|
-19.1 milligram per deciliter (mg/dL)
Standard Deviation 40.04
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Baseline (n = 253)
|
151.8 milligram per deciliter (mg/dL)
Standard Deviation 48.68
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at Month 1 (n = 160)
|
-16.7 milligram per deciliter (mg/dL)
Standard Deviation 40.47
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at Month 3 (n = 198)
|
-17.1 milligram per deciliter (mg/dL)
Standard Deviation 47.05
|
—
|
|
Change From Baseline in Fasting Blood Glucose
Change at final assessment (n = 253)
|
-17.2 milligram per deciliter (mg/dL)
Standard Deviation 44.25
|
—
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)Population: The efficacy assessment population was defined as participants who completed the study and had fasting insulin data at baseline and post-baseline time points available.
The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.
Outcome measures
| Measure |
Alogliptin + Biguanides
n=32 Participants
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
Alogliptin + Other
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
|---|---|---|
|
Change From Baseline in Fasting Insulin Level
Change at Month 1 (n = 21)
|
1.79 microunits per milliliter
Standard Deviation 5.485
|
—
|
|
Change From Baseline in Fasting Insulin Level
Change at Month 3 (n = 18)
|
2.21 microunits per milliliter
Standard Deviation 6.305
|
—
|
|
Change From Baseline in Fasting Insulin Level
Change at Month 6 (n = 24)
|
0.04 microunits per milliliter
Standard Deviation 4.913
|
—
|
|
Change From Baseline in Fasting Insulin Level
Baseline (n = 32)
|
9.00 microunits per milliliter
Standard Deviation 6.712
|
—
|
|
Change From Baseline in Fasting Insulin Level
Change at Month 12 (n = 19)
|
-1.21 microunits per milliliter
Standard Deviation 3.711
|
—
|
|
Change From Baseline in Fasting Insulin Level
Change at final assessment (n = 32)
|
-0.25 microunits per milliliter
Standard Deviation 5.286
|
—
|
Adverse Events
Alogliptin + Biguanides
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Alogliptin + Other
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alogliptin + Biguanides
n=954 participants at risk
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
Alogliptin + Other
n=109 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.10%
1/954 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
0.00%
0/109 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.10%
1/954 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
0.00%
0/109 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.10%
1/954 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
0.00%
0/109 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.10%
1/954 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
0.00%
0/109 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.10%
1/954 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
0.00%
0/109 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
Other adverse events
| Measure |
Alogliptin + Biguanides
n=954 participants at risk
Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
Alogliptin + Other
n=109 participants at risk
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.10%
1/954 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
0.00%
0/109 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.31%
3/954 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
0.00%
0/109 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.10%
1/954 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
0.00%
0/109 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
|
Nervous system disorders
Dysgeusia
|
0.10%
1/954 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
0.92%
1/109 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
|
Nervous system disorders
Somnolence
|
0.10%
1/954 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
0.00%
0/109 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.10%
1/954 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
0.00%
0/109 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
|
Gastrointestinal disorders
Constipation
|
0.21%
2/954 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
0.00%
0/109 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
|
Gastrointestinal disorders
Nausea
|
0.21%
2/954 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
0.00%
0/109 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.21%
2/954 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
0.00%
0/109 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/954 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
0.92%
1/109 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/954 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
0.92%
1/109 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.52%
5/954 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
0.00%
0/109 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.10%
1/954 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
0.00%
0/109 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
|
Renal and urinary disorders
Renal disorder
|
0.10%
1/954 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
0.00%
0/109 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
|
General disorders
Feeling abnormal
|
0.21%
2/954 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
0.00%
0/109 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
|
Investigations
Weight increased
|
0.10%
1/954 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
0.00%
0/109 • Baseline up to 12 months.
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. Only adverse drug reactions were collected in the safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER