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Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes

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:
NCT01204775
First received: September 16, 2010
Last updated: February 19, 2015
Last verified: April 2014
History of Changes

September 16, 2010
February 19, 2015
June 2011
December 2015   (final data collection date for primary outcome measure)
To compare after 16 weeks of oral double-blind treatment the change from baseline in HbA1c achieved with Saxagliptin and placebo [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
To compare after 16 weeks of oral double-blind treatment the change from baseline in HbA1c achieved with saxagliptin and placebo [ Time Frame: 16 weeks (or last measurement prior if no Week 16 assessment is available) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01204775 on ClinicalTrials.gov Archive Site
  • To compare after 16 weeks of oral double-blind treatment the effects of Saxagliptin versus placebo treatment on the AUC change from baseline in 2-hour PPG levels, as determined from samples obtained during Mixed Meal Tolerance Test (MMTT). [ Time Frame: 16 weeks (or last measurement prior if no Week 16 assessment is available) ] [ Designated as safety issue: No ]
    Area under the curve (AUC), Postprandial Glucose (PPG)
  • To compare after 16 weeks of oral double-blind treatment the effects of Saxagliptin versus placebo treatment on the change from baseline in Fasting Plasma Glucose (FPG). [ Time Frame: 16 weeks (or last measurement prior if no Week 16 assessment is available) ] [ Designated as safety issue: No ]
  • To compare after 16 weeks of oral double-blind treatment the effects of Saxagliptin versus placebo treatment on the percent of subjects who achieved Glycosylated hemoglobin (HbA1c) < 7% [ Time Frame: 16 weeks (or last measurement prior if no Week 16 assessment is available) ] [ Designated as safety issue: No ]
  • The effects of saxagliptin versus placebo treatment on The Area under the curve (AUC) change from baseline in 2-hour Postprandial Glucose (PPG) levels, as determined from samples obtained during Mixed Meal Tolerance Test (MMTT) [ Time Frame: 16 weeks (or last measurement prior if no Week 16 assessment is available) ] [ Designated as safety issue: No ]
  • The change from baseline in Fasting Plasma Glucose (FPG) [ Time Frame: 16 weeks (or last measurement prior if no Week 16 assessment is available) ] [ Designated as safety issue: No ]
  • The percent of subjects who achieved Glycosylated hemoglobin (HbA1c) < 7% [ Time Frame: 16 weeks (or last measurement prior if no Week 16 assessment is available) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin (BMS-477118) as Monotherapy in Pediatric Patients With Type 2 Diabetes

The purpose of this study is to evaluate the efficacy, safety, tolerability, of Saxagliptin in pediatric patients with type 2 diabetes.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Saxagliptin
    Tablets, Oral, 2.5 mg or 5.0 mg (according to body weight category), Once Daily, 1-52 weeks
    Other Names:
    • BMS-477118
    • Onglyza
  • Drug: Placebo (Saxagliptin)
    Tablets, Oral, 0 mg, Once daily, 1-52 weeks
  • Drug: Metformin IR
    Tablets, Oral, 500 mg, Once Daily, 17-52 weeks
  • Drug: Placebo (Metformin)
    Tablets, Oral, 0 mg, Once daily, 1-52 weeks
  • Drug: Metformin (Active Rescue)
    Tablets, Oral, 500 mg, Titrated as needed, 2-52 weeks
  • Active Comparator: Saxagliptin or Placebo
    Interventions:
    • Drug: Saxagliptin
    • Drug: Placebo (Saxagliptin)
  • Active Comparator: Metformin IR or Placebo
    Interventions:
    • Drug: Metformin IR
    • Drug: Placebo (Metformin)
  • Metformin IR
    Active Rescue
    Intervention: Drug: Metformin (Active Rescue)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
136
April 2017
December 2015   (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 32 weeks of age at the time of randomization.
  • HbA1c ≥7.0% and ≤10.5%

Exclusion Criteria:

  • Current use of anti-diabetic medications or use within the specified timeframe prior to screening.
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,   Argentina,   Belgium,   Canada,   India,   Israel,   Italy,   Russian Federation,   South Africa,   Taiwan,   Turkey
Australia,   United Kingdom
 
NCT01204775
CV181-058, 2010-020360-38
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