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
Study identifier:CV181-147
ClinicalTrials.gov identifier:NCT01434186
EudraCT identifier:2010-024568-16
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Diabetes Mellitus, Type 2
Phase
Phase 3
Healthy volunteers
No
Study drug
Placebo matching with Saxagliptin, Metformin IR, Metformin XR, Saxagliptin
Sex
All
Actual Enrollment
32
Study type
Interventional
Age
10 Years - 17 Years
Date
Study Start Date: 01 May 2012
Primary Completion Date: 01 Apr 2016
Study Completion Date: 01 Apr 2016
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2017 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Bristol Myers Squibb
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1: Saxagliptin +Metformin XR/IR Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject’s weight) Metformin XR/IR 1000 mg-2000 mg | Drug: Metformin IR Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52 Drug: Metformin XR Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52 Drug: Saxagliptin Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject’s weight) Other Name: BMS-477118 |
| Placebo Comparator: Arm 2: Placebo +Metformin XR/IR Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg | Drug: Placebo matching with Saxagliptin Tablet, Oral, 0.0 mg, Daily, Day 1 through week 52 Drug: Metformin IR Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52 Drug: Metformin XR Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52 |
Contacts
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
