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
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ClinicalTrials.gov Identifier: NCT01434186 |
Recruitment Status
:
Completed
First Posted
: September 14, 2011
Results First Posted
: April 18, 2017
Last Update Posted
: April 18, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Drug: Placebo matching with Saxagliptin Drug: Metformin IR Drug: Metformin XR Drug: Saxagliptin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | April 2016 |
Actual Study Completion Date : | April 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: 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
|
Drug: Metformin IR
Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52
Drug: Metformin XR
Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52
Drug: Saxagliptin
Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight)
Other Name: BMS-477118
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Placebo Comparator: Arm 2: Placebo +Metformin XR/IR
Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg
|
Drug: Placebo matching with Saxagliptin
Tablet, Oral, 0.0 mg, Daily, Day 1 through week 52
Drug: Metformin IR
Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52
Drug: Metformin XR
Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52
|
- Mean Change in HbA1c From Baseline to Week 16 [ Time Frame: 16 week short term treatment period ]

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Ages Eligible for Study: | 10 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434186
United States, California | |
Research Site | |
Los Angeles, California, United States | |
United States, Florida | |
Research Site | |
Tallahassee, Florida, United States | |
United States, Michigan | |
Research Site | |
Dearborn, Michigan, United States | |
United States, Minnesota | |
Research Site | |
St. Paul, Minnesota, United States | |
United States, New York | |
Research Site | |
Mineola, New York, United States | |
United States, Ohio | |
Research Site | |
Cleveland, Ohio, United States | |
United States, Tennessee | |
Research Site | |
Memphis, Tennessee, United States | |
Belgium | |
Research Site | |
Namur, Belgium | |
Canada, Alberta | |
Research Site | |
Calgary, Alberta, Canada | |
India | |
Research Site | |
Bangalore, India | |
Mexico | |
Research Site | |
Aguascalientes, Mexico | |
Research Site | |
Meridas, Mexico | |
Research Site | |
Monterrey, Mexico | |
Research Site | |
Veracruz, Mexico | |
Taiwan | |
Research Site | |
Taichung, Taiwan | |
United Kingdom | |
Research Site | |
Leicester, United Kingdom |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT01434186 History of Changes |
Other Study ID Numbers: |
CV181-147 2010-024568-16 ( EudraCT Number ) |
First Posted: | September 14, 2011 Key Record Dates |
Results First Posted: | April 18, 2017 |
Last Update Posted: | April 18, 2017 |
Last Verified: | March 2017 |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Saxagliptin Metformin Hypoglycemic Agents |
Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |