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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 ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01434186
First received: September 13, 2011
Last updated: October 17, 2016
Last verified: October 2016

September 13, 2011
October 17, 2016
May 2012
April 2017   (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
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 or in Combination with Baseline Insulin Therapy
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/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
    Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight)
    Other Name: BMS-477118
  • 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
    Interventions:
    • Drug: Metformin IR
    • Drug: Metformin XR
    • Drug: Saxagliptin
  • Placebo Comparator: Arm 2: Placebo +Metformin XR/IR
    Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg
    Interventions:
    • Drug: Placebo matching with Saxagliptin
    • Drug: Metformin IR
    • 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.
 
Active, not recruiting
224
April 2017
April 2017   (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   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   India,   Israel,   Mexico,   Russian Federation,   South Africa,   Taiwan,   Turkey,   United Kingdom
Argentina,   Italy
 
NCT01434186
CV181-147, 2010-024568-16
Yes
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
AstraZeneca
October 2016

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