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 currently recruiting participants. (see Contacts and Locations)
Verified April 2014 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: October 13, 2014
Last verified: April 2014

September 13, 2011
October 13, 2014
November 2011
January 2016   (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.
 
Recruiting
224
September 2016
January 2016   (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: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.
United States,   India,   South Africa,   United Kingdom,   Taiwan,   Argentina,   Belgium,   Canada,   Israel,   Italy,   Mexico
 
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
April 2014

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