drugset
drugset / Trial / NCT01434186

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

NCT01434186 ↗

Phase 3 Completed 32 enrolled AstraZeneca Bristol-Myers Squibb · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination with Metformin in pediatric patients with type 2 diabetes

Timeline

Start
2012-05
Primary completion
2016-04
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject SAXAGLIPTIN ANHYDROUS Small molecule 2.5 mg Oral
Subject SAXAGLIPTIN ANHYDROUS Small molecule 5 mg Oral
Background Metformin IR Unknown 1000 mg Oral
Background Metformin IR Unknown 2000 mg Oral
Background Metformin XR Small molecule 1000 mg Oral
Background Metformin XR Small molecule 2000 mg Oral

Indications

type 2 diabetes mellitus