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Effect of Vildagliptin vs. Glibenclamide on Circulating Endothelial Progenitor Cell Number Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01822548
Recruitment Status : Completed
First Posted : April 2, 2013
Results First Posted : August 2, 2017
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Ivana Zavaroni, Azienda Ospedaliero-Universitaria di Parma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes
Interventions Drug: Vildagliptin
Drug: Glibenclamide
Drug: Metformin
Enrollment 64
Recruitment Details Individuals with type 2 diabetes were recruited in the outpatient Diabetes Unit of Parma University Hospital
Pre-assignment Details  
Arm/Group Title Vildagliptin & Metformin Glibenclamide & Metformin
Hide Arm/Group Description

Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration

Vildagliptin: 100 mg daily

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.

Period Title: Overall Study
Started 40 [1] 24
Discontinued Intervention 0 5
Completed 40 24
Not Completed 0 0
[1]
Received allocated intervention n=38 Did not receive allocated intervention (only metformin) n=2
Arm/Group Title Vildagliptin & Metformin Glibenclamide & Metformin Total
Hide Arm/Group Description

Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration

Vildagliptin: 100 mg daily

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 of all reporting groups
Overall Number of Baseline Participants 40 24 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 24 participants 64 participants
61  (9) 63  (10) 62  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 24 participants 64 participants
Female
14
  35.0%
7
  29.2%
21
  32.8%
Male
26
  65.0%
17
  70.8%
43
  67.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 24 participants 64 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
40
 100.0%
24
 100.0%
64
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 24 participants 64 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
40
 100.0%
24
 100.0%
64
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 40 participants 24 participants 64 participants
40 24 64
Body Mass Index  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 40 participants 24 participants 64 participants
29.1
(26.8 to 32.9)
28.9
(25.4 to 34.1)
29.0
(26.2 to 33.9)
HBA1C  
Median (Inter-Quartile Range)
Unit of measure:  %
Number Analyzed 40 participants 24 participants 64 participants
7.7
(7.4 to 7.9)
7.7
(7.5 to 8.1)
7.7
(7.4 to 8.1)
Endothelial Progenitor Cells Number  
Median (Inter-Quartile Range)
Unit of measure:  EPC/10^6 cells
Number Analyzed 40 participants 24 participants 64 participants
39
(24.0 to 58.2)
37.5
(25.0 to 59.8)
38
(24.2 to 58.2)
1.Primary Outcome
Title Absolute Change in the Endothelial Progenitor Cell (EPC) Number
Hide Description 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.
Time Frame V0, V2 (month 4), V4 (12 month)
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Hide Analysis Population Description
Intention to treat (ITT) analysis
Arm/Group Title Vildagliptin & Metformin Glibenclamide & Metformin
Hide Arm/Group Description:

Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration

Vildagliptin: 100 mg daily

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 Number of Participants Analyzed 40 24
Median (Inter-Quartile Range)
Unit of Measure: EPC/10^6 cells
V2 (4 month)
37
(27.0 to 65.0)
36
(23.0 to 54.2)
V4 (12 month)
45
(29.7 to 67)
32
(22.2 to 53.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vildagliptin & Metformin, Glibenclamide & Metformin
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Regression, Linear
Comments Generalized linear model (GLM)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Vildagliptin & Metformin, Glibenclamide & Metformin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments adjustment for baseline value of EPC
Method of Estimation Estimation Parameter Slope
Estimated Value 0.362
Confidence Interval (2-Sided) 95%
0.028 to 0.695
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Absolute Change in HbA1C Compared to Baseline
Hide Description The secondary endpoint was the change from baseline values of HbA1C in the Vildagliptin vs Glibenclamide arm at 4 and 12 months
Time Frame V0 (randomization), V2 (month4), V4 (month 12).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vildagliptin & Metformin Glibenclamide & Metformin
Hide Arm/Group Description:

Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration

Vildagliptin: 100 mg daily

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 Number of Participants Analyzed 40 24
Median (Inter-Quartile Range)
Unit of Measure: percentage
V2 (4 month)
6.8
(6.4 to 7.3)
6.8
(6.4 to 7.3)
V4 (12 month)
7.0
(6.5 to 7.3)
7.1
(6.5 to 7.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vildagliptin & Metformin, Glibenclamide & Metformin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -0.067
Confidence Interval (2-Sided) 95%
-0.358 to 0.224
Estimation Comments [Not Specified]
Time Frame 4 months
Adverse Event Reporting Description Hypoglycemia
 
Arm/Group Title Vildagliptin & Metformin Glibenclamide & Metformin
Hide Arm/Group Description

Vildagliptin 100 mg tablet and metformin (max dose=2500 mg) tablet daily oral administration

Vildagliptin: 100 mg daily

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.

All-Cause Mortality
Vildagliptin & Metformin Glibenclamide & Metformin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vildagliptin & Metformin Glibenclamide & Metformin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/40 (0.00%)      0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vildagliptin & Metformin Glibenclamide & Metformin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/40 (0.00%)      5/24 (20.83%)    
Metabolism and nutrition disorders     
hypoglycemia  [1]  0/40 (0.00%)  0 5/24 (20.83%)  5
Indicates events were collected by systematic assessment
[1]
At each study visit side effects were systematically investigated and patients were asked to contact the centre in case of adverse events.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Prof.ssa Ivana Zavaroni
Organization: Azienda ospedaliero-universitaria di Parma
Phone: +390521033306
Responsible Party: Ivana Zavaroni, Azienda Ospedaliero-Universitaria di Parma
ClinicalTrials.gov Identifier: NCT01822548     History of Changes
Other Study ID Numbers: 2012-005399-32
First Submitted: March 28, 2013
First Posted: April 2, 2013
Results First Submitted: March 6, 2017
Results First Posted: August 2, 2017
Last Update Posted: August 2, 2017