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 Small molecule 1000 mg Oral
Background Metformin Small molecule 2000 mg Oral

Indications

type 2 diabetes mellitus