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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

This study is not yet open for participant recruitment.
Verified February 2012 by Bristol-Myers Squibb
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01434186
First received: September 13, 2011
Last updated: April 30, 2012
Last verified: February 2012
History of Changes

September 13, 2011
April 30, 2012
April 2012
May 2014   (final data collection date for primary outcome measure)
Mean change in Glycosylated hemoglobin (HbA1c) in the short term treatment period [ Time Frame: Baseline and upto Week 16 (or the last post-baseline measurement prior to Week 16, if no Week 16 assessment is available) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01434186 on ClinicalTrials.gov Archive Site
  • Mean change in 2-hour Postprandial Glucose (PPG) Area under the curve (AUC) in the short term treatment period [ Time Frame: Baseline and upto Week 16 (or the last post-baseline measurement prior to Week 16, if no Week 16 assessment is available) ] [ Designated as safety issue: No ]
  • Mean change in FPG (Fasting plasma glucose) in the short term treatment period [ Time Frame: Baseline and upto Week 16 (or the last post-baseline measurement prior to Week 16, if no Week 16 assessment is available) ] [ Designated as safety issue: No ]
  • Percent of subjects with HbA1c < 7% in the short term treatment period [ Time Frame: At Week 16 (or the last post-baseline measurement prior to Week 16, if no Week 16 assessment is available) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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

To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination with Metformin in pediatric patients with type 2 diabetes
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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
  • Drug: Saxagliptin
    Tablet, Oral, 2.5 mg for body weight 30kg to ≤ 50kg, Daily, Day 1 through week 52
    Other Name: BMS-477118
  • Drug: Saxagliptin
    Tablet, Oral, 5 mg for the body weight >50 kg, Daily, Day 1 through week 52
    Other Name: BMS-477118
  • Experimental: Arm 1: Saxagliptin + Metformin IR
    Interventions:
    • Drug: Metformin IR
    • Drug: Saxagliptin
    • Drug: Saxagliptin
  • Experimental: Arm 2: Placebo for Saxagliptin + Metformin IR
    Interventions:
    • Drug: Placebo matching with Saxagliptin
    • Drug: Metformin IR
  • Experimental: Arm 3: Saxagliptin + Metformin XR
    Interventions:
    • Drug: Metformin XR
    • Drug: Saxagliptin
    • Drug: Saxagliptin
  • Experimental: Arm 4: Placebo for Saxagliptin + Metformin XR
    Interventions:
    • Drug: Placebo matching with Saxagliptin
    • Drug: Metformin XR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
224
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
10 Years to 17 Years
No
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.
United States,   Argentina,   Belgium,   Canada,   Israel,   Italy,   Mexico,   Russian Federation,   South Africa,   Taiwan,   Turkey,   United Kingdom
 
NCT01434186
CV181-147, 2010-024568-16
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
AstraZeneca
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP