Status:
COMPLETED
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
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01434186
Start Date
May 1 2012
End Date
April 1 2016
Last Update
April 18 2017
Active Locations (16)
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1
Research Site
Los Angeles, California, United States
2
Research Site
Tallahassee, Florida, United States
3
Research Site
Dearborn, Michigan, United States
4
Research Site
Saint Paul, Minnesota, United States