At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 32 enrolled
Drug / intervention
Placebo matching with Saxagliptin +3 moredrug
Likely dose
Placebo matching with Saxagliptin 0.0 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 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination With Metformin IR or Metformin XR in Pediatric Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone
In Brief
A Phase 3 clinical trial evaluating Placebo matching with Saxagliptin, Metformin IR, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 32 participants across 16 sites in 7 countries.
Detailed Summary
To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination with Metformin in pediatric patients with type 2 diabetes
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesBelgium, Canada, India, Mexico, Taiwan, United Kingdom, United States
CollaboratorsBristol-Myers Squibb
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 2011
Enrollment StartMay 2012
Primary CompletionApr 2016
TodayJul 2026
First PostedSep 14, 2011
Enrollment StartMay 1, 2012
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 14.8 years ago
Interventions
Placebo matching with Saxagliptindrug
Tablet, Oral, 0.0 mg, Daily, Day 1 through week 52
Metformin IRdrug
Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52
Metformin XRdrug
Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52
Saxagliptindrug
Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight)