Trial Outcomes & Findings for Effect of Vildagliptin vs. Glibenclamide on Circulating Endothelial Progenitor Cell Number Type 2 Diabetes (NCT NCT01822548)
NCT ID: NCT01822548
Last Updated: 2017-08-02
Results Overview
The study primary endpoint was the change from baseline values of the EPC number in the Vildagliptin vs Glibenclamide arm at 4 and 12 months.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
64 participants
Primary outcome timeframe
V0, V2 (month 4), V4 (12 month)
Results posted on
2017-08-02
Participant Flow
Individuals with type 2 diabetes were recruited in the outpatient Diabetes Unit of Parma University Hospital
Participant milestones
| Measure |
Vildagliptin & Metformin
Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration
Vildagliptin: 100 mg daily
|
Glibenclamide & Metformin
Glibenclamide maximum dose of 10 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration
Glibenclamide: 2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
24
|
|
Overall Study
Discontinued Intervention
|
0
|
5
|
|
Overall Study
COMPLETED
|
40
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Vildagliptin vs. Glibenclamide on Circulating Endothelial Progenitor Cell Number Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Vildagliptin & Metformin
n=40 Participants
Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration
Vildagliptin: 100 mg daily
|
Glibenclamide & Metformin
n=24 Participants
Glibenclamide maximum dose of 10 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration
Glibenclamide: 2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 9 • n=5 Participants
|
63 years
STANDARD_DEVIATION 10 • n=7 Participants
|
62 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
40 participants
n=5 Participants
|
24 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Body Mass Index
|
29.1 kg/m^2
n=5 Participants
|
28.9 kg/m^2
n=7 Participants
|
29.0 kg/m^2
n=5 Participants
|
|
HBA1C
|
7.7 %
n=5 Participants
|
7.7 %
n=7 Participants
|
7.7 %
n=5 Participants
|
|
Endothelial Progenitor Cells Number
|
39 EPC/10^6 cells
n=5 Participants
|
37.5 EPC/10^6 cells
n=7 Participants
|
38 EPC/10^6 cells
n=5 Participants
|
PRIMARY outcome
Timeframe: V0, V2 (month 4), V4 (12 month)Population: Intention to treat (ITT) analysis
The study primary endpoint was the change from baseline values of the EPC number in the Vildagliptin vs Glibenclamide arm at 4 and 12 months.
Outcome measures
| Measure |
Vildagliptin & Metformin
n=40 Participants
Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration
Vildagliptin: 100 mg daily
|
Glibenclamide & Metformin
n=24 Participants
Glibenclamide maximum dose of 10 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration
Glibenclamide: 2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day.
|
|---|---|---|
|
Absolute Change in the Endothelial Progenitor Cell (EPC) Number
V2 (4 month)
|
37 EPC/10^6 cells
Interval 27.0 to 65.0
|
36 EPC/10^6 cells
Interval 23.0 to 54.2
|
|
Absolute Change in the Endothelial Progenitor Cell (EPC) Number
V4 (12 month)
|
45 EPC/10^6 cells
Interval 29.7 to 67.0
|
32 EPC/10^6 cells
Interval 22.2 to 53.5
|
SECONDARY outcome
Timeframe: V0 (randomization), V2 (month4), V4 (month 12).The secondary endpoint was the change from baseline values of HbA1C in the Vildagliptin vs Glibenclamide arm at 4 and 12 months
Outcome measures
| Measure |
Vildagliptin & Metformin
n=40 Participants
Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration
Vildagliptin: 100 mg daily
|
Glibenclamide & Metformin
n=24 Participants
Glibenclamide maximum dose of 10 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration
Glibenclamide: 2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day.
|
|---|---|---|
|
Absolute Change in HbA1C Compared to Baseline
V2 (4 month)
|
6.8 percentage
Interval 6.4 to 7.3
|
6.8 percentage
Interval 6.4 to 7.3
|
|
Absolute Change in HbA1C Compared to Baseline
V4 (12 month)
|
7.0 percentage
Interval 6.5 to 7.3
|
7.1 percentage
Interval 6.5 to 7.5
|
Adverse Events
Vildagliptin & Metformin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Glibenclamide & Metformin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vildagliptin & Metformin
n=40 participants at risk
Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration
Vildagliptin: 100 mg daily
|
Glibenclamide & Metformin
n=24 participants at risk
Glibenclamide maximum dose of 10 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration
Glibenclamide: 2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day.
|
|---|---|---|
|
Metabolism and nutrition disorders
hypoglycemia
|
0.00%
0/40 • 4 months
Hypoglycemia
|
20.8%
5/24 • Number of events 5 • 4 months
Hypoglycemia
|
Additional Information
Prof.ssa Ivana Zavaroni
Azienda ospedaliero-universitaria di Parma
Phone: +390521033306
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place