At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 26 enrolled
Drug / intervention
Saxagliptin +4 moredrug
Likely dose
Saxagliptin 2.5 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, Safety, Tolerability, and Pharmacokinetics of Saxagliptin (BMS-477118) as Monotherapy in Pediatric Patients With Type 2 Diabetes
In Brief
A Phase 3 clinical trial evaluating Saxagliptin, Placebo (Saxagliptin), and 3 other interventions for Type 2 Diabetes. Completed, enrolled 26 participants across 16 sites in 4 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy, safety, tolerability, of Saxagliptin in pediatric patients with type 2 diabetes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesRussia, South Africa, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2010
Enrollment StartJun 2011
Primary CompletionApr 2016
TodayJul 2026
First PostedSep 17, 2010
Enrollment StartJun 1, 2011
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 15.8 years ago
Interventions
Saxagliptindrug
Tablets, Oral, 2.5 mg or 5.0 mg (according to body weight category), Once Daily, 1-52 weeks
Placebo (Saxagliptin)drug
Tablets, Oral, Once daily, 1-16 weeks
Metformin IRdrug
Tablets, Oral, 500 mg, Once Daily, 17-52 weeks
Placebo (Metformin)drug
Tablets, Oral, Once daily, 1-16 weeks
Metformin (Active Rescue)drug
Tablets, Oral, 500 mg, Titrated as needed, 2-52 weeks