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
Status: | Active, not recruiting |
---|---|
Conditions: | Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 10 - 17 |
Updated: | 4/21/2016 |
Start Date: | November 2011 |
End Date: | April 2017 |
To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination
with Metformin in pediatric patients with type 2 diabetes
with Metformin in pediatric patients with type 2 diabetes
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
We found this trial at
36
sites
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Miami Children's Hospital Welcome to Miami Children
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4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
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Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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