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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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

Key facts

Study ID

NCT01434186

Run by

AstraZeneca

People needed

32

Starts

2012-05-01

Expected to finish

2016-04-01

Last updated by the study team

2017-04-18

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Los Angeles, California, United States
• Research Site — Tallahassee, Florida, United States
• Research Site — Dearborn, Michigan, United States
• Research Site — Saint Paul, Minnesota, United States
• Research Site — Mineola, New York, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Memphis, Tennessee, United States
• Research Site — Namur, Belgium
• Research Site — Calgary, Alberta, Canada
• Research Site — Bangalore, India
• Research Site — Aguascalientes, Mexico
• Research Site — Meridas, Mexico
• Research Site — Monterrey, Mexico
• Research Site — Veracruz, Mexico
• Research Site — Taichung, Taiwan
• Research Site — Leicester, United Kingdom

Full record on ClinicalTrials.gov

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