Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatments saxagliptin, placebo (saxagliptin), metformin ir, placebo (metformin), metformin (active rescue)
Phase phase 3
Sponsor Bristol-Myers Squibb
Collaborator AstraZeneca
Start date June 2011
End date June 2016
Trial size 9 participants
Trial identifier NCT01204775, 2010-020360-38, CV181-058

Summary

The purpose of this study is to evaluate the efficacy, safety, tolerability, of Saxagliptin in pediatric patients with type 2 diabetes.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
saxagliptin BMS-477118
Tablets, Oral, 2.5 mg or 5.0 mg (according to body weight category), Once Daily, 1-52 weeks
placebo (saxagliptin)
Tablets, Oral, 0 mg, Once daily, 1-52 weeks
(Active Comparator)
metformin ir
Tablets, Oral, 500 mg, Once Daily, 17-52 weeks
placebo (metformin)
Tablets, Oral, 0 mg, Once daily, 1-52 weeks
(Other)
Active Rescue
metformin (active rescue)
Tablets, Oral, 500 mg, Titrated as needed, 2-52 weeks

Primary Outcomes

Measure
To compare after 16 weeks of oral double-blind treatment the change from baseline in HbA1c achieved with Saxagliptin and placebo
time frame: 16 weeks

Secondary Outcomes

Measure
To compare after 16 weeks of oral double-blind treatment the effects of Saxagliptin versus placebo treatment on the AUC change from baseline in 2-hour PPG levels, as determined from samples obtained during Mixed Meal Tolerance Test (MMTT).
time frame: 16 weeks (or last measurement prior if no Week 16 assessment is available)
To compare after 16 weeks of oral double-blind treatment the effects of Saxagliptin versus placebo treatment on the change from baseline in Fasting Plasma Glucose (FPG).
time frame: 16 weeks (or last measurement prior if no Week 16 assessment is available)
To compare after 16 weeks of oral double-blind treatment the effects of Saxagliptin versus placebo treatment on the percent of subjects who achieved Glycosylated hemoglobin (HbA1c) < 7%
time frame: 16 weeks (or last measurement prior 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 32 weeks of age at the time of randomization. - HbA1c ≥7.0% and ≤10.5% Exclusion Criteria: - Current use of anti-diabetic medications or use within the specified timeframe prior to screening.

Additional Information

Official title A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin (BMS-477118) as Monotherapy in Pediatric Patients With Type 2 Diabetes
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.