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 - Full Text View

Purpose

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

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Placebo matching with Saxagliptin Drug: Metformin IR Drug: Metformin XR Drug: Saxagliptin	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Investigator Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Metformin Metformin hydrochloride Saxagliptin

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Mean Change in HbA1c From Baseline to Week 16 [ Time Frame: 16 week short term treatment period ]


Enrollment:	32
Study Start Date:	May 2012
Study Completion Date:	April 2016
Primary Completion Date:	April 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	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
Placebo Comparator: Arm 2: Placebo +Metformin XR/IR Placebo matching saxagliptin 0 mg Metformin XR/IR 1000 mg - 2000 mg	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

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

Eligibility


Ages Eligible for Study:	10 Years to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434186

Locations


United States, California
Research Site
Los Angeles, California, United States
United States, Florida
Research Site
Tallahassee, Florida, United States
United States, Michigan
Research Site
Dearborn, Michigan, United States
United States, Minnesota
Research Site
St. Paul, Minnesota, United States
United States, New York
Research Site
Mineola, New York, United States
United States, Ohio
Research Site
Cleveland, Ohio, United States
United States, Tennessee
Research Site
Memphis, Tennessee, United States
Belgium
Research Site
Namur, Belgium
Canada, Alberta
Research Site
Calgary, Alberta, Canada
India
Research Site
Bangalore, India
Mexico
Research Site
Aguascalientes, Mexico
Research Site
Meridas, Mexico
Research Site
Monterrey, Mexico
Research Site
Veracruz, Mexico
Taiwan
Research Site
Taichung, Taiwan
United Kingdom
Research Site
Leicester, United Kingdom

Sponsors and Collaborators

AstraZeneca

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

Additional Information:

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site


Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01434186 History of Changes
Other Study ID Numbers:	CV181-147 2010-024568-16 ( EudraCT Number )
Study First Received:	September 13, 2011
Results First Received:	March 7, 2017
Last Updated:	March 7, 2017

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Saxagliptin Metformin Hypoglycemic Agents	Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 26, 2017