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
NCT ID: NCT01434186
Last Updated: 2017-04-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
32 participants
INTERVENTIONAL
2012-05-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1: Saxagliptin +Metformin XR/IR
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
Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight)
Arm 2: Placebo +Metformin XR/IR
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
Interventions
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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
Saxagliptin
Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
10 Years
17 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Research Site
Los Angeles, California, United States
Research Site
Tallahassee, Florida, United States
Research Site
Dearborn, Michigan, United States
Countries
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Other Identifiers
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2010-024568-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CV181-147
Identifier Type: -
Identifier Source: org_study_id
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