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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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo matching with Saxagliptin
Metformin IR
Metformin XR
Saxagliptin
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1: Saxagliptin +Metformin XR/IR

Arm 2: Placebo +Metformin XR/IR

Arm Description

Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight) Metformin XR/IR 1000 mg-2000 mg

Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg

Outcomes

Primary Outcome Measures

Mean Change in HbA1c From Baseline to Week 16

Secondary Outcome Measures

Full Information

First Posted
September 13, 2011
Last Updated
March 7, 2017
Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01434186
Brief 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
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the efficacy, safety, tolerability, of Saxagliptin (BMS-477118) in combination with Metformin in pediatric patients with type 2 diabetes
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Tallahassee
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Dearborn
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
St. Paul
State/Province
Minnesota
Country
United States
Facility Name
Research Site
City
Mineola
State/Province
New York
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Namur
Country
Belgium
Facility Name
Research Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Bangalore
Country
India
Facility Name
Research Site
City
Aguascalientes
Country
Mexico
Facility Name
Research Site
City
Meridas
Country
Mexico
Facility Name
Research Site
City
Monterrey
Country
Mexico
Facility Name
Research Site
City
Veracruz
Country
Mexico
Facility Name
Research Site
City
Taichung
Country
Taiwan
Facility Name
Research Site
City
Leicester
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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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