Trial Outcomes & Findings for Study to Evaluate the Efficacy of Acarbose,Metformin,Sitagliptin Combination Treatment in DM Patients (NCT NCT01490918)
NCT ID: NCT01490918
Last Updated: 2020-08-17
Results Overview
The change of glycated hemoglogin(HbA1c) from baseline to 16 weeks of treatment between Placebo + Metformin+Sitagliptin and Metformin + Sitagliptin + Acarbose group
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
165 participants
Primary outcome timeframe
baseline, 16 weeks
Results posted on
2020-08-17
Participant Flow
Participant milestones
| Measure |
Acarbose Placebo, Metformin, Sitagliptin
Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks.
|
Sitagliptin, Metformin, Acarbose
Metformin and sitagliptin and acarbose treatment for 24 weeks.
|
Metformin Placebo, Sitagliptin, Acarbose
Placebo and sitagliptin and acarbose treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks. The Metformin placebo should be changed into real Metformin from the 16th week.
|
|---|---|---|---|
|
Overall Study
STARTED
|
65
|
66
|
34
|
|
Overall Study
COMPLETED
|
52
|
52
|
22
|
|
Overall Study
NOT COMPLETED
|
13
|
14
|
12
|
Reasons for withdrawal
| Measure |
Acarbose Placebo, Metformin, Sitagliptin
Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks.
|
Sitagliptin, Metformin, Acarbose
Metformin and sitagliptin and acarbose treatment for 24 weeks.
|
Metformin Placebo, Sitagliptin, Acarbose
Placebo and sitagliptin and acarbose treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks. The Metformin placebo should be changed into real Metformin from the 16th week.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
8
|
3
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
other cause
|
4
|
5
|
8
|
Baseline Characteristics
Study to Evaluate the Efficacy of Acarbose,Metformin,Sitagliptin Combination Treatment in DM Patients
Baseline characteristics by cohort
| Measure |
Acarbose Placebo, Metformin, Sitagliptin
n=65 Participants
The dose of Acarbose should be 50mg b.i.d, 50mg t.i.d and 100mg t.i.d at the 18th week, the 20th week and the 24th week respectively. The Acarbose placebo should be changed into real Acarbose from the 16th week.
Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively
|
Sitagliptin, Metformin, Acarbose
n=66 Participants
The group's drugs not include placebo. (Metformin, Sitagliptin, Acarbose)
Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively
|
Metformin Placebo, Sitagliptin, Acarbose
n=34 Participants
The Metformin placebo should be changed into real Metformin from the 16th week.
Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.55 years
STANDARD_DEVIATION 10.51 • n=99 Participants
|
60.89 years
STANDARD_DEVIATION 8.8 • n=107 Participants
|
60.15 years
STANDARD_DEVIATION 9.92 • n=206 Participants
|
59.03 years
STANDARD_DEVIATION 9.88 • n=7 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
87 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
78 Participants
n=7 Participants
|
|
Region of Enrollment
South Korea
|
65 participants
n=99 Participants
|
66 participants
n=107 Participants
|
34 participants
n=206 Participants
|
165 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: baseline, 16 weeksPopulation: ITT: intention to treatment, All subject randomized to each treatment group
The change of glycated hemoglogin(HbA1c) from baseline to 16 weeks of treatment between Placebo + Metformin+Sitagliptin and Metformin + Sitagliptin + Acarbose group
Outcome measures
| Measure |
Placebo+Metformin+Sitagliptin
n=65 Participants
Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks as triple combination of acarbose + metformin + sitagliptin
|
Sitagliptin+Metformin+Acarbose
n=66 Participants
Metformin and sitagliptin and acarbose treatment for 24 weeks.
|
Placebo+Sitagliptin+Acarbose
n=34 Participants
Placebo and sitagliptin and acarbose treatment for 16 weeks. The placebo will be changed to Metformin from the 16th week and maintained another 8 week for triple combination of metformin + sitagliptin + acarbose.
|
|---|---|---|---|
|
The Change of Glycated Hemoglogin(HbA1c) From Baseline to 16 Weeks of Treatment
|
-0.09 % of HbA1c
Standard Error 0.1
|
-0.44 % of HbA1c
Standard Error 0.08
|
0.84 % of HbA1c
Standard Error 0.21
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: ITT: intention to treatment, All subject randomized to each treatment group
The change of glycated hemoglogin(HbA1c) from baseline to 24 weeks of treatment between 3 groups
Outcome measures
| Measure |
Placebo+Metformin+Sitagliptin
n=65 Participants
Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks as triple combination of acarbose + metformin + sitagliptin
|
Sitagliptin+Metformin+Acarbose
n=66 Participants
Metformin and sitagliptin and acarbose treatment for 24 weeks.
|
Placebo+Sitagliptin+Acarbose
n=34 Participants
Placebo and sitagliptin and acarbose treatment for 16 weeks. The placebo will be changed to Metformin from the 16th week and maintained another 8 week for triple combination of metformin + sitagliptin + acarbose.
|
|---|---|---|---|
|
The Change of HbA1c From Baseline to 24 Weeks of Treatment
|
-0.34 % of HbA1c
Standard Deviation 0.82
|
-0.47 % of HbA1c
Standard Deviation 0.78
|
0.23 % of HbA1c
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: ITT: intention to treatment, All subject randomized to each treatment group
The change of PPG2hr (post prandia blood glucose 2hr from baseline to 24 weeks of treatment between 3 groups
Outcome measures
| Measure |
Placebo+Metformin+Sitagliptin
n=63 Participants
Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks as triple combination of acarbose + metformin + sitagliptin
|
Sitagliptin+Metformin+Acarbose
n=66 Participants
Metformin and sitagliptin and acarbose treatment for 24 weeks.
|
Placebo+Sitagliptin+Acarbose
n=34 Participants
Placebo and sitagliptin and acarbose treatment for 16 weeks. The placebo will be changed to Metformin from the 16th week and maintained another 8 week for triple combination of metformin + sitagliptin + acarbose.
|
|---|---|---|---|
|
The Change of PPG2hr From Baseline to 24 Weeks of Treatment
|
-1.73 mmol/L
Standard Deviation 3.38
|
-1.76 mmol/L
Standard Deviation 3.53
|
0.06 mmol/L
Standard Deviation 4.53
|
SECONDARY outcome
Timeframe: Visit 2(baseline) and Visit 5(16W)Change of AUC(area under the curve) of glucose at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)
Outcome measures
| Measure |
Placebo+Metformin+Sitagliptin
n=12 Participants
Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks as triple combination of acarbose + metformin + sitagliptin
|
Sitagliptin+Metformin+Acarbose
n=13 Participants
Metformin and sitagliptin and acarbose treatment for 24 weeks.
|
Placebo+Sitagliptin+Acarbose
Placebo and sitagliptin and acarbose treatment for 16 weeks. The placebo will be changed to Metformin from the 16th week and maintained another 8 week for triple combination of metformin + sitagliptin + acarbose.
|
|---|---|---|---|
|
Changes in Glucose During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),
|
28.85 mg min/dL
Standard Deviation 2168.64
|
-743.08 mg min/dL
Standard Deviation 1278.28
|
—
|
SECONDARY outcome
Timeframe: Visit 2(baseline) and Visit 5(16W)Change of AUC(area under the curve) of insulin at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)
Outcome measures
| Measure |
Placebo+Metformin+Sitagliptin
n=13 Participants
Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks as triple combination of acarbose + metformin + sitagliptin
|
Sitagliptin+Metformin+Acarbose
n=12 Participants
Metformin and sitagliptin and acarbose treatment for 24 weeks.
|
Placebo+Sitagliptin+Acarbose
Placebo and sitagliptin and acarbose treatment for 16 weeks. The placebo will be changed to Metformin from the 16th week and maintained another 8 week for triple combination of metformin + sitagliptin + acarbose.
|
|---|---|---|---|
|
Changes in Insulin During Mixed Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),
|
647.65 pg min/mL
Standard Deviation 3854.75
|
221.42 pg min/mL
Standard Deviation 8339.6
|
—
|
SECONDARY outcome
Timeframe: baseline, 16 weekChange of active GLP-1 at 0 minute during mixed meal test at 16 week from baseline between 2 groups(group1, group2)
Outcome measures
| Measure |
Placebo+Metformin+Sitagliptin
n=12 Participants
Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks as triple combination of acarbose + metformin + sitagliptin
|
Sitagliptin+Metformin+Acarbose
n=13 Participants
Metformin and sitagliptin and acarbose treatment for 24 weeks.
|
Placebo+Sitagliptin+Acarbose
Placebo and sitagliptin and acarbose treatment for 16 weeks. The placebo will be changed to Metformin from the 16th week and maintained another 8 week for triple combination of metformin + sitagliptin + acarbose.
|
|---|---|---|---|
|
Change in Active GLP-1 at 0 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2)
|
-8.55 pg/ml
Standard Deviation 19.01
|
-9.33 pg/ml
Standard Deviation 31.12
|
—
|
SECONDARY outcome
Timeframe: baseline, 16 weekChange of active GLP-1 at 120 minute during mixed meal test at 16 week from baseline between 2 groups(group1, group2)
Outcome measures
| Measure |
Placebo+Metformin+Sitagliptin
n=12 Participants
Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks as triple combination of acarbose + metformin + sitagliptin
|
Sitagliptin+Metformin+Acarbose
n=13 Participants
Metformin and sitagliptin and acarbose treatment for 24 weeks.
|
Placebo+Sitagliptin+Acarbose
Placebo and sitagliptin and acarbose treatment for 16 weeks. The placebo will be changed to Metformin from the 16th week and maintained another 8 week for triple combination of metformin + sitagliptin + acarbose.
|
|---|---|---|---|
|
Change in Active GLP-1 at 120 Minute During Mixed Meal Test Between 2 Groups (Group 1, group2)
|
-32.92 pg/ml
Standard Deviation 21.78
|
-23.36 pg/ml
Standard Deviation 33.43
|
—
|
SECONDARY outcome
Timeframe: Visit 2(baseline) and Visit 5(16W)Change of AUC(area under the curve) of glucagon at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)
Outcome measures
| Measure |
Placebo+Metformin+Sitagliptin
n=9 Participants
Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks as triple combination of acarbose + metformin + sitagliptin
|
Sitagliptin+Metformin+Acarbose
n=9 Participants
Metformin and sitagliptin and acarbose treatment for 24 weeks.
|
Placebo+Sitagliptin+Acarbose
Placebo and sitagliptin and acarbose treatment for 16 weeks. The placebo will be changed to Metformin from the 16th week and maintained another 8 week for triple combination of metformin + sitagliptin + acarbose.
|
|---|---|---|---|
|
Changes in Glucagon During Meal Tolerance Test Between 2 Group(Group 1 vs Group 2),
|
-79.22 min pg/mL
Standard Deviation 833.59
|
-1411.79 min pg/mL
Standard Deviation 1049.41
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 2(baseline) and Visit 5(16W)Change of mean glucose of CGMS(continuous glucose monitoring system) data at 16 week from baseline between 3 groups
Outcome measures
| Measure |
Placebo+Metformin+Sitagliptin
n=11 Participants
Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks as triple combination of acarbose + metformin + sitagliptin
|
Sitagliptin+Metformin+Acarbose
n=13 Participants
Metformin and sitagliptin and acarbose treatment for 24 weeks.
|
Placebo+Sitagliptin+Acarbose
n=6 Participants
Placebo and sitagliptin and acarbose treatment for 16 weeks. The placebo will be changed to Metformin from the 16th week and maintained another 8 week for triple combination of metformin + sitagliptin + acarbose.
|
|---|---|---|---|
|
Changes in Mean Glucose During CGMS Between 3 Group
|
-0.91 mmol/L
Standard Deviation 0.81
|
-1.16 mmol/L
Standard Deviation 0.49
|
3.22 mmol/L
Standard Deviation 1.25
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 2(baseline) and Visit 5(16W)Change of standard deviation of CGMS(continuous glucose monitoring system) data at 16 week from baseline between 3 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin vs placebo + acarbose + sitagliptin)
Outcome measures
| Measure |
Placebo+Metformin+Sitagliptin
n=11 Participants
Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks as triple combination of acarbose + metformin + sitagliptin
|
Sitagliptin+Metformin+Acarbose
n=13 Participants
Metformin and sitagliptin and acarbose treatment for 24 weeks.
|
Placebo+Sitagliptin+Acarbose
n=6 Participants
Placebo and sitagliptin and acarbose treatment for 16 weeks. The placebo will be changed to Metformin from the 16th week and maintained another 8 week for triple combination of metformin + sitagliptin + acarbose.
|
|---|---|---|---|
|
Changes in Variation of Glucose During CGMS Between 3 Group
|
-0.33 mmol/L
Standard Deviation 1.0
|
-0.65 mmol/L
Standard Deviation 0.8
|
0.03 mmol/L
Standard Deviation 0.29
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 2(baseline) and Visit 5(16W)Change of mean amplitude of glycemic excursion of CGMS(continuous glucose monitoring system) data at 16 week from baseline between 2 groups (placebo+metformin + sitagliptin vs acarbose + metformin + sitagliptin)
Outcome measures
| Measure |
Placebo+Metformin+Sitagliptin
n=11 Participants
Metformin and sitagliptin and placebo treatment for 16 weeks. Placebo was changed to acarbose at 16 week and maintained for another 8 weeks as triple combination of acarbose + metformin + sitagliptin
|
Sitagliptin+Metformin+Acarbose
n=13 Participants
Metformin and sitagliptin and acarbose treatment for 24 weeks.
|
Placebo+Sitagliptin+Acarbose
n=6 Participants
Placebo and sitagliptin and acarbose treatment for 16 weeks. The placebo will be changed to Metformin from the 16th week and maintained another 8 week for triple combination of metformin + sitagliptin + acarbose.
|
|---|---|---|---|
|
Changes in MAGE of Glucose During CGMS Between 2 Group(Group 1 vs Group 2),
|
-8.79 mg/dL
Standard Deviation 15.01
|
-18.5 mg/dL
Standard Deviation 13.23
|
2.72 mg/dL
Standard Deviation 2.72
|
Adverse Events
Acarbose Placebo, Metformin, Sitagliptin
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Sitagliptin, Metformin, Acarbose
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Metformin Placebo, Sitagliptin, Acarbose
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Acarbose Placebo, Metformin, Sitagliptin
n=65 participants at risk
The dose of Acarbose should be 50mg b.i.d, 50mg t.i.d and 100mg t.i.d at the 18th week, the 20th week and the 24th week respectively. The Acarbose placebo should be changed into real Acarbose from the 16th week.
Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively
|
Sitagliptin, Metformin, Acarbose
n=66 participants at risk
The group's drugs not include placebo. (Metformin, Sitagliptin, Acarbose)
Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively
|
Metformin Placebo, Sitagliptin, Acarbose
n=34 participants at risk
The Metformin placebo should be changed into real Metformin from the 16th week.
Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively
|
|---|---|---|---|
|
General disorders
chest pain
|
1.5%
1/65 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/66 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Musculoskeletal and connective tissue disorders
lumbar spinal stenosis
|
1.5%
1/65 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/66 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
1.5%
1/66 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
Other adverse events
| Measure |
Acarbose Placebo, Metformin, Sitagliptin
n=65 participants at risk
The dose of Acarbose should be 50mg b.i.d, 50mg t.i.d and 100mg t.i.d at the 18th week, the 20th week and the 24th week respectively. The Acarbose placebo should be changed into real Acarbose from the 16th week.
Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively
|
Sitagliptin, Metformin, Acarbose
n=66 participants at risk
The group's drugs not include placebo. (Metformin, Sitagliptin, Acarbose)
Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively
|
Metformin Placebo, Sitagliptin, Acarbose
n=34 participants at risk
The Metformin placebo should be changed into real Metformin from the 16th week.
Acarbose: The dose of Acarbose or its placebo should be 50mg b.i.d at first. At the 2nd week and the 4th week, it should be 50mg t.i.d and 100mg t.i.d respectively
|
|---|---|---|---|
|
Eye disorders
cataract
|
1.5%
1/65 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/66 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Eye disorders
visual acuity reduced
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/66 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
2.9%
1/34 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Gastrointestinal disorders
abdominal discomfort
|
3.1%
2/65 • Number of events 2 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
3.0%
2/66 • Number of events 2 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Gastrointestinal disorders
abdominal distension
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
1.5%
1/66 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
2.9%
1/34 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
1.5%
1/66 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Gastrointestinal disorders
chronic gastritis
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/66 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
2.9%
1/34 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Gastrointestinal disorders
constipation
|
1.5%
1/65 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
1.5%
1/66 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Gastrointestinal disorders
dental caries
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
1.5%
1/66 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Gastrointestinal disorders
diarrhea
|
1.5%
1/65 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
1.5%
1/66 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Gastrointestinal disorders
dyspepsia
|
3.1%
2/65 • Number of events 2 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
9.1%
6/66 • Number of events 6 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Gastrointestinal disorders
flatulence
|
1.5%
1/65 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
3.0%
2/66 • Number of events 2 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Gastrointestinal disorders
large intestinal polyp
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/66 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
2.9%
1/34 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Gastrointestinal disorders
nausea
|
1.5%
1/65 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
1.5%
1/66 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
2.9%
1/34 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Gastrointestinal disorders
toothcache
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
1.5%
1/66 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Gastrointestinal disorders
vomiting
|
1.5%
1/65 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
1.5%
1/66 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
General disorders
chest pain
|
1.5%
1/65 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/66 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Infections and infestations
hordeolum
|
1.5%
1/65 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/66 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Infections and infestations
nasopharyngitis
|
1.5%
1/65 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
3.0%
2/66 • Number of events 3 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
2.9%
1/34 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
1.5%
1/66 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Injury, poisoning and procedural complications
laceration
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/66 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
2.9%
1/34 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Injury, poisoning and procedural complications
tooth fracture
|
1.5%
1/65 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/66 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Injury, poisoning and procedural complications
wrist fracture
|
1.5%
1/65 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/66 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Investigations
ALT increased
|
1.5%
1/65 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/66 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Investigations
AST increased
|
1.5%
1/65 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/66 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Investigations
liver function test abnormal
|
1.5%
1/65 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/66 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Metabolism and nutrition disorders
diabetes mellitus inadequate controll
|
1.5%
1/65 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/66 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Metabolism and nutrition disorders
hyperglycemia
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/66 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
11.8%
4/34 • Number of events 4 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Metabolism and nutrition disorders
hypoglycemia
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
1.5%
1/66 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
2.9%
1/34 • Number of events 2 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Musculoskeletal and connective tissue disorders
lumbar spinal stenosis
|
1.5%
1/65 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/66 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/66 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
2.9%
1/34 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
1.5%
1/66 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Musculoskeletal and connective tissue disorders
spinal osteoarthritis
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
1.5%
1/66 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
uterine leimyoma
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
1.5%
1/66 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Nervous system disorders
dizziness
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
1.5%
1/66 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
2.9%
1/34 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Nervous system disorders
paresthesia
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/66 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
2.9%
1/34 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Nervous system disorders
tremor
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
1.5%
1/66 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Renal and urinary disorders
prorteinuria
|
1.5%
1/65 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/66 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Reproductive system and breast disorders
pelvic pain
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
1.5%
1/66 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Skin and subcutaneous tissue disorders
pruritus
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
3.0%
2/66 • Number of events 2 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Skin and subcutaneous tissue disorders
skin exfoliation
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
1.5%
1/66 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
|
Skin and subcutaneous tissue disorders
vitiligo
|
0.00%
0/65 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
1.5%
1/66 • Number of events 1 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
0.00%
0/34 • 24 weeks
total number afffected by any other adverse event : included SAEs
|
Additional Information
Yoon Hee Choi
The Catholic University of Korea, Seoul St Mary's Hospital
Phone: 82-2-2258-8288
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place