At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 2,004 enrolled
Drug / intervention
Placebo of vildagliptin +2 moredrug
Likely dose
vildagliptin 50 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.
A 5-year Study to Compare the Durability of Glycemic Control of a Combination Regimen With Vildagliptin & Metformin Versus Standard-of-care Monotherapy With Metformin, Initiated in Treatment-naïve Patients With Type 2 Diabetes Mellitus
In Brief
A Phase 4 clinical trial evaluating Placebo of vildagliptin, vildagliptin, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 2,004 participants across 227 sites in 34 countries.
Detailed Summary
The purpose of this study was to determine whether the initiation of a vildagliptin plus metformin combination regimen would result in more durable glycemic control than metformin monotherapy in treatment-naïve patients with type-2 diabetes mellitus (T2DM).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesArgentina, Australia, Austria, Brazil, Bulgaria, Colombia, Czechia, Dominican Republic, Estonia, Finland, Germany, Guatemala, Hong Kong, Hungary, India, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Norway, Panama, Peru, Philippines, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye)
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2012
Enrollment StartMar 2012
Primary CompletionApr 2019
TodayJul 2026
First PostedFeb 7, 2012
Enrollment StartMar 30, 2012
Primary CompletionApr 4, 2019
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 14.4 years ago
Interventions
Placebo of vildagliptindrug
vildagliptindrug
One tablet (50 mg oral) of vildagliptin in the morning and one tablet in the evening with or without food.
Metformindrug
Twice daily (bid) regimen during or after meals at the same time as vildagliptin.