Trial Outcomes & Findings for Comparison of Vildagliptin vs. Glimepiride on Glucose Variability in Metformin Uncontrolled Type 2 Diabetic Patients (NCT NCT01910441)
NCT ID: NCT01910441
Last Updated: 2015-10-28
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
95 participants
Primary outcome timeframe
16 weeks
Results posted on
2015-10-28
Participant Flow
Participant milestones
| Measure |
Group A: Vildagliptin Plus Metformin
Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
|
Group B: Glimepiride Plus Metformin
Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
47
|
|
Overall Study
COMPLETED
|
41
|
37
|
|
Overall Study
NOT COMPLETED
|
7
|
10
|
Reasons for withdrawal
| Measure |
Group A: Vildagliptin Plus Metformin
Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
|
Group B: Glimepiride Plus Metformin
Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
|
|---|---|---|
|
Overall Study
Sponsor decision
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
6
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Non-compliance
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Comparison of Vildagliptin vs. Glimepiride on Glucose Variability in Metformin Uncontrolled Type 2 Diabetic Patients
Baseline characteristics by cohort
| Measure |
Group A: Vildagliptin Plus Metformin
n=48 Participants
Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
|
Group B: Glimepiride Plus Metformin
n=47 Participants
Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.7 Years
STANDARD_DEVIATION 11.86 • n=99 Participants
|
52.1 Years
STANDARD_DEVIATION 9.29 • n=107 Participants
|
50.9 Years
STANDARD_DEVIATION 10.68 • n=206 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: The study was prematurely terminated due to the unavailability of CGMS required for the assessment of the primary end point. The non-availability of CGMS severely affected participant recruitment. The primary outcome was not analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Group A: Vildagliptin Plus Metformin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group B: Glimepiride Plus Metformin
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: Vildagliptin Plus Metformin
n=48 participants at risk
Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
|
Group B: Glimepiride Plus Metformin
n=47 participants at risk
Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
|
|---|---|---|
|
Nervous system disorders
HEADACHE
|
0.00%
0/48
|
2.1%
1/47
|
|
Psychiatric disorders
RESTLESSNESS
|
0.00%
0/48
|
2.1%
1/47
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/48
|
2.1%
1/47
|
Other adverse events
| Measure |
Group A: Vildagliptin Plus Metformin
n=48 participants at risk
Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
|
Group B: Glimepiride Plus Metformin
n=47 participants at risk
Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
|
|---|---|---|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
8.3%
4/48
|
2.1%
1/47
|
Additional Information
Study Director
Novartis
Phone: 862-778-8200
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER