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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Metformin IR; Drug: Placebo matching with Saxagliptin; Drug: Metformin XR; Drug: Saxagliptin

• Registration Number: NCT01434186
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

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 or in Combination with Baseline Insulin Therapy

Study Timeline

• Study First Submitted: 2011-09-13
• Study First Submitted QC: 2011-09-13
• Study First Posted: 2011-09-14
• Study Start: 2012-05
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-03
• Results First Submitted: 2017-03-07
• Results First Submitted QC: 2017-03-07
• Last Update Submitted: 2017-03-07
• Results First Posted: 2017-04-18
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Male and female patients eligible if 10 years of age, up to 17 years and 30 weeks of age at the time of screening
• Previously diagnosed as having type 2 diabetes
• HbA1c ≥7.0% and ≤10.5%
• Body weight ≥ 30 kg
• Stable dose of metformin (≥ 1000mg - ≤ 2000mg) for a minimum of 2 months
• Women must have a negative serum or urine pregnancy test
• Women must not be breastfeeding

Exclusion Criteria

• Current use of anti-diabetic medications or use within the specified timeframe prior to screening (Exception: Metformin)
• Fasting plasma glucose (FPG) > 255 mg/dL
• Diabetic ketoacidosis (DKA) within 6 months of study entry
• Abnormal renal function
• Active liver disease
• Anemia
• An abnormal Thyroid Stimulating Hormone (TSH)
• Creatinine kinase (CK) ≥ 3X ULN

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Saxagliptin +Metformin XR/IR	Metformin XR	Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) Metformin XR/IR 1000 mg-2000 mg
Arm 1: Saxagliptin +Metformin XR/IR	Metformin IR	Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) Metformin XR/IR 1000 mg-2000 mg
Arm 2: Placebo +Metformin XR/IR	Metformin XR	Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg
Arm 2: Placebo +Metformin XR/IR	Placebo matching with Saxagliptin	Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg
Arm 2: Placebo +Metformin XR/IR	Metformin IR	Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg
Arm 1: Saxagliptin +Metformin XR/IR	Saxagliptin	Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) Metformin XR/IR 1000 mg-2000 mg

Primary Outcome Measures

Name	Time	Method
Mean Change in HbA1c From Baseline to Week 16	16 week short term treatment period

Trial Locations

Locations (1)

Research Site; 🇬🇧 Leicester, United Kingdom