At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 42 enrolled
Drug / intervention
Vildagliptin +3 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.
Randomized, Open-label, SU-controlled Study of 24-week Duration to Compare Metformin/Vildagliptin + Basal Insulin Versus Metformin/SU + Basal Insulin in T2DM Patients Starting Basal Insulin After Failing Metformin/SU
In Brief
A Phase 3 clinical trial evaluating Vildagliptin, Metformin, and 2 other interventions for Type 2 Diabetes Mellitus (T2DM). Completed, enrolled 42 participants across 19 sites.
Detailed Summary
To compare a therapeutic strategy combining vildagliptin+metformin + Basal Insulin versus SU+metformin + Basal Insulin on the incidence of hypoglycemic events over 24 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus (T2DM)
CountriesFrance
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJun 2013
First PostedJun 2013
Primary CompletionFeb 2015
TodayJul 2026
First PostedJun 6, 2013
Enrollment StartJun 1, 2013
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.1 years ago
Interventions
Vildagliptindrug
50 mg b.i.d
Metformindrug
metformin is to be kept unchanged
sulfonylurea (SU)drug
Basal Insulindrug