Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 2
Treatments placebo matching with saxagliptin, metformin ir, metformin xr, saxagliptin
Phase phase 3
Sponsor AstraZeneca
Collaborator Bristol-Myers Squibb
Start date May 2012
End date April 2017
Trial size 224 participants
Trial identifier NCT01434186, 2010-024568-16, CV181-147

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) Metformin XR/IR 1000 mg-2000 mg
metformin ir
Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52
metformin xr
Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52
saxagliptin BMS-477118
Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight)
(Placebo Comparator)
Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg
placebo matching with saxagliptin
Tablet, Oral, 0.0 mg, Daily, Day 1 through week 52
metformin ir
Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52
metformin xr
Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52

Primary Outcomes

Measure
Mean change in Glycosylated hemoglobin (HbA1c) in the short term treatment period
time frame: Baseline and upto Week 16 (or the last post-baseline measurement prior to Week 16, if no Week 16 assessment is available)

Secondary Outcomes

Measure
Mean change in 2-hour Postprandial Glucose (PPG) Area under the curve (AUC) in the short term treatment period
time frame: Baseline and upto Week 16 (or the last post-baseline measurement prior to Week 16, if no Week 16 assessment is available)
Mean change in FPG (Fasting plasma glucose) in the short term treatment period
time frame: Baseline and upto Week 16 (or the last post-baseline measurement prior to Week 16, if no Week 16 assessment is available)
Percent of subjects with HbA1c < 7% in the short term treatment period
time frame: At Week 16 (or the last post-baseline measurement prior to Week 16, if no Week 16 assessment is available)

Eligibility Criteria

Male or female participants from 10 years up to 17 years old.

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

Additional Information

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
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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.