At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 64 enrolled
Drug / intervention
Vildagliptin +2 moredrug
Likely dose
Vildagliptin 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Open Label, Two Parallel Arms, Intervention Trial Comparing the Effect of DPP-IV Inhibitor Vildagliptin vs. Glibenclamide on Circulating Endothelial Progenitor Cell Number in Patients With Type 2 Diabetes in Metformin Failure
In Brief
A Phase 3 clinical trial evaluating Vildagliptin, Glibenclamide, and 1 other intervention for Type 2 Diabetes. Completed, enrolled 64 participants across 2 sites.
Detailed Summary
The purpose of this study is to evaluate the effect of Dipeptidyl peptidase (DPP) -IV inhibitor Vildagliptin vs. Glibenclamide on circulating endothelial progenitor cells (EPCs) number in type 2 diabetes patients in metformin failure. Subjects will be followed for 12 months after randomization.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesItaly
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2010
First PostedApr 2013
Primary CompletionDec 2014
Study CompletionJan 2015
TodayJul 2026
First PostedApr 2, 2013
Enrollment StartOct 1, 2010
Primary CompletionDec 1, 2014
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 13.3 years ago
Interventions
Vildagliptindrug
100 mg daily
Glibenclamidedrug
2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day.
Metformindrug
concomitant therapy with metformin is present in each arm (MAX dose: 2500 mg/die)