Trial Outcomes & Findings for Safety and Efficacy Study to Compare Vildagliptin to Pioglitazone as Adding on Metformin in Type 2 Diabetes (NCT NCT01882907)
NCT ID: NCT01882907
Last Updated: 2019-03-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
287 participants
Primary outcome timeframe
16 weeks
Results posted on
2019-03-21
Participant Flow
Total number of patients who were in screening is 287. However, 59 patients were excluded. 49 Patients didn't meet inclusion/exclusion criteria. 10 Patients didn't take investigational product. As a result, 228 patients took investigational product.
Participant milestones
| Measure |
Vildagliptin
vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
vildagliptin: vildagliptin 50mg bid for 16 weeks
|
Pioglitazone
Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
Pioglitazone: Pioglitazone 15mg bid for 16 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
117
|
111
|
|
Overall Study
COMPLETED
|
103
|
83
|
|
Overall Study
NOT COMPLETED
|
14
|
28
|
Reasons for withdrawal
| Measure |
Vildagliptin
vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
vildagliptin: vildagliptin 50mg bid for 16 weeks
|
Pioglitazone
Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
Pioglitazone: Pioglitazone 15mg bid for 16 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Protocol Violation
|
10
|
14
|
|
Overall Study
Withdrawal by Subject
|
0
|
6
|
Baseline Characteristics
Safety and Efficacy Study to Compare Vildagliptin to Pioglitazone as Adding on Metformin in Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Vildagliptin
n=117 Participants
vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
vildagliptin: vildagliptin 50mg bid for 16 weeks
|
Pioglitazone
n=111 Participants
Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
Pioglitazone: Pioglitazone 15mg bid for 16 weeks
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 9.8 • n=99 Participants
|
53.9 years
STANDARD_DEVIATION 9.1 • n=107 Participants
|
54.5 years
STANDARD_DEVIATION 9.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Body Mass Index
|
24.9 Kg/m^2
STANDARD_DEVIATION 3.2 • n=99 Participants
|
25.0 Kg/m^2
STANDARD_DEVIATION 3.3 • n=107 Participants
|
24.9 Kg/m^2
STANDARD_DEVIATION 3.3 • n=206 Participants
|
|
Duration of diaebetes
|
68.3 months
STANDARD_DEVIATION 62.0 • n=99 Participants
|
60.2 months
STANDARD_DEVIATION 58.6 • n=107 Participants
|
64.3 months
STANDARD_DEVIATION 60.4 • n=206 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: This number is analyzed subjects population(Vildagliptin group n=115, Pioglitazone group n=108). It is excluded the patients who are screening failure and not available to efficacy assessment.
Outcome measures
| Measure |
Vildagliptin
n=115 Participants
vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
vildagliptin: vildagliptin 50mg bid for 16 weeks
|
Pioglitazone
n=108 Participants
Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
Pioglitazone: Pioglitazone 15mg bid for 16 weeks
|
|---|---|---|
|
Non-inferiority of HbA1C Change From Baseline in Vildagliptin + Metformin Group Compared With Pioglitazone + Metformin Group
|
-0.94 % (change of HbA1c)
Standard Deviation 0.79
|
-0.60 % (change of HbA1c)
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: 16 weeks , visit 5Population: This number is analyzed subjects population(Vildagliptin group n=115, Pioglitazone group n=108). It is excluded the patients who are screening failure and not available to efficacy assessment.
1. After 16 weeks, to assess the effect of vildagliptin compared with the effect of pioglitazone on Fasting Plasma Glucose (FPG) 2. After 16 weeks, to assess the effect of vildagliptin compared with the effect of pioglitazone on Postprandial Glucose (PPG)
Outcome measures
| Measure |
Vildagliptin
n=115 Participants
vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
vildagliptin: vildagliptin 50mg bid for 16 weeks
|
Pioglitazone
n=108 Participants
Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
Pioglitazone: Pioglitazone 15mg bid for 16 weeks
|
|---|---|---|
|
the Mean Changes of FPG and PPG From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups
FBG levels difference
|
-20.41 mg/dL
Standard Deviation 34.81
|
-15.04 mg/dL
Standard Deviation 38.15
|
|
the Mean Changes of FPG and PPG From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups
PPG levels difference
|
-60.23 mg/dL
Standard Deviation 75.48
|
-38.19 mg/dL
Standard Deviation 83.79
|
SECONDARY outcome
Timeframe: 16 weeks, visit 5Population: This number is analyzed subjects population(Vildagliptin group n=115, Pioglitazone group n=108). It is excluded the patients who are screening failure and not available to efficacy assessment.
The Mean Changes of Lipid Profiles(Triglyceride, Total cholesterol, LDL, HDL, Non-HDL cholesterol) From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups after 16weeks
Outcome measures
| Measure |
Vildagliptin
n=115 Participants
vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
vildagliptin: vildagliptin 50mg bid for 16 weeks
|
Pioglitazone
n=108 Participants
Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
Pioglitazone: Pioglitazone 15mg bid for 16 weeks
|
|---|---|---|
|
the Mean Changes of Lipid Profiles From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups
Triglyceride
|
-9.22 mg/dL
Standard Deviation 55.98
|
-4.79 mg/dL
Standard Deviation 67.83
|
|
the Mean Changes of Lipid Profiles From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups
Total cholesterol
|
-6.45 mg/dL
Standard Deviation 25.10
|
9.60 mg/dL
Standard Deviation 33.83
|
|
the Mean Changes of Lipid Profiles From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups
LDL
|
-6.03 mg/dL
Standard Deviation 21.20
|
5.38 mg/dL
Standard Deviation 30.37
|
|
the Mean Changes of Lipid Profiles From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups
HDL
|
-0.34 mg/dL
Standard Deviation 8.57
|
3.69 mg/dL
Standard Deviation 10.33
|
|
the Mean Changes of Lipid Profiles From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups
Non-HDL cholesterol
|
-8.39 mg/dL
Standard Deviation 24.67
|
5.79 mg/dL
Standard Deviation 32.72
|
SECONDARY outcome
Timeframe: 16 weeks, visit 5Population: This number is analyzed subjects population(Vildagliptin group n=115, Pioglitazone group n=108). It is excluded the patients who are screening failure and not available to efficacy assessment.
Outcome measures
| Measure |
Vildagliptin
n=115 Participants
vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
vildagliptin: vildagliptin 50mg bid for 16 weeks
|
Pioglitazone
n=108 Participants
Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
Pioglitazone: Pioglitazone 15mg bid for 16 weeks
|
|---|---|---|
|
the Mean Changes of Body Weight From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups
|
-0.07 kg
Standard Deviation 1.53
|
0.69 kg
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: 16 weeks, visit 5Population: This number is analyzed subjects population(Vildagliptin group n=115, Pioglitazone group n=108). It is excluded the patients who are screening failure and not available to efficacy assessment.
Outcome measures
| Measure |
Vildagliptin
n=115 Participants
vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
vildagliptin: vildagliptin 50mg bid for 16 weeks
|
Pioglitazone
n=108 Participants
Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
Pioglitazone: Pioglitazone 15mg bid for 16 weeks
|
|---|---|---|
|
the Mean Changes of Insulin, C-peptide, HOMA-IR, HOMA-beta From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups
Insulin difference
|
0.36 mcU/mL*mmol/L
Standard Deviation 6.95
|
-8.21 mcU/mL*mmol/L
Standard Deviation 70.06
|
|
the Mean Changes of Insulin, C-peptide, HOMA-IR, HOMA-beta From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups
C-peptide difference
|
0.07 mcU/mL*mmol/L
Standard Deviation 0.84
|
-0.24 mcU/mL*mmol/L
Standard Deviation 1.14
|
|
the Mean Changes of Insulin, C-peptide, HOMA-IR, HOMA-beta From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups
HOMA-IR difference
|
-0.06 mcU/mL*mmol/L
Standard Deviation 2.92
|
-3.33 mcU/mL*mmol/L
Standard Deviation 25.16
|
|
the Mean Changes of Insulin, C-peptide, HOMA-IR, HOMA-beta From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups
HOMA-beta difference
|
9.77 mcU/mL*mmol/L
Standard Deviation 28.10
|
-24.26 mcU/mL*mmol/L
Standard Deviation 294.88
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 16 weeks, visit 3,4,5Population: This number is subject population who were exposure the drug(Vildagliptin group n=117, Pioglitazone group n=111). It is excluded the patients who are screening failure.
Outcome measures
| Measure |
Vildagliptin
n=117 Participants
vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
vildagliptin: vildagliptin 50mg bid for 16 weeks
|
Pioglitazone
n=111 Participants
Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
Pioglitazone: Pioglitazone 15mg bid for 16 weeks
|
|---|---|---|
|
the Numbers of Participants With Adverse Events Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups
Number of incidence
|
27 participants
|
25 participants
|
|
the Numbers of Participants With Adverse Events Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups
Number of adverse events
|
48 participants
|
37 participants
|
Adverse Events
Vildagliptin
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Pioglitazone
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vildagliptin
n=117 participants at risk
vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
vildagliptin: vildagliptin 50mg bid for 16 weeks
|
Pioglitazone
n=111 participants at risk
Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
Pioglitazone: Pioglitazone 15mg bid for 16 weeks
|
|---|---|---|
|
Immune system disorders
Urinary tract infection
|
0.85%
1/117 • Number of events 1
|
0.00%
0/111
|
|
Nervous system disorders
Dizziness
|
0.00%
0/117
|
1.8%
2/111 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Injury of ligament
|
0.85%
1/117 • Number of events 1
|
0.00%
0/111
|
|
Cardiac disorders
Myocardial infarction
|
0.85%
1/117 • Number of events 1
|
0.00%
0/111
|
|
Infections and infestations
Upper respiration infection
|
0.85%
1/117 • Number of events 1
|
0.90%
1/111 • Number of events 1
|
Other adverse events
| Measure |
Vildagliptin
n=117 participants at risk
vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
vildagliptin: vildagliptin 50mg bid for 16 weeks
|
Pioglitazone
n=111 participants at risk
Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy
Pioglitazone: Pioglitazone 15mg bid for 16 weeks
|
|---|---|---|
|
Infections and infestations
Common cold
|
2.6%
3/117
|
3.6%
4/111
|
|
Infections and infestations
Upper respiration infection
|
3.4%
4/117
|
0.00%
0/111
|
|
Gastrointestinal disorders
Nausea
|
2.6%
3/117
|
1.8%
2/111
|
|
Gastrointestinal disorders
Diarrhea
|
2.6%
3/117
|
0.90%
1/111
|
|
Gastrointestinal disorders
Dyspepsia
|
2.6%
3/117
|
0.00%
0/111
|
|
Nervous system disorders
Dizziness
|
0.00%
0/117
|
3.6%
4/111
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60