An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00643851
First received: March 20, 2008
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

The purpose of this clinical research study is to learn if initiating treatment with BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes, when compared to initial treatment with monotherapy dapagliflozin or metformin XR. The safety of this treatment will also be studied


Condition Intervention Phase
Type 2 Diabetes
Drug: Dapagliflozin
Drug: Metformin XR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin as Initial Therapy as Compared With Dapagliflozin Monotherapy and Metformin Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change from baseline in hemoglobin A1C [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose achieved with Dapagliflozin in Combination with Metformin compared to Dapagliflozin Monotherapy and compared to Metformin Monotherapy [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving a therapeutic glycemic response, defined as A1C < 7.0% [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in total body weight [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in A1C (A1C category ≥9.0%) [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in total body weight (baseline BMI category ≥27 kg/m2) [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]

Enrollment: 600
Study Start Date: June 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Dapagliflozin (5 mg) + Metformin XR (up to 2000 mg)
Drug: Dapagliflozin
Tablets, Oral, Once daily, 24 weeks
Other Name: BMS-512148
Drug: Metformin XR
Tablets, Oral, Once daily, 24 weeks
Experimental: Arm 2
Dapagliflozin (5 mg)
Drug: Dapagliflozin
Tablets, Oral, Once daily, 24 weeks
Other Name: BMS-512148
Active Comparator: Arm 3
Metformin XR (500 mg up to 2000 mg)
Drug: Metformin XR
Tablets, Oral, Once daily, 24 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 77 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males & females, 18-77 years old inclusive, with type 2 diabetes and with inadequate glycemic control
  • Drug naive or treated with anti-diabetic medication for < 24 weeks since original diagnosis
  • C-peptide ≥ 1.0 ng/mL
  • Body Mass Index ≤ 45.0 kg/m
  • Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women

Exclusion Criteria:

  • AST and/or ALT >3.0 times the upper limit of normal (ULN)
  • Serum total bilirubin > 2.0 mg/dL
  • Creatine kinase > 3X the upper limit of normal (ULN)
  • Symptoms of severely uncontrolled diabetes
  • Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric or rheumatic diseases
  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: NCT00643851

  Show 99 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00643851     History of Changes
Other Study ID Numbers: MB102-021
Study First Received: March 20, 2008
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
China: Food and Drug Administration
India: Central Drugs Standard Control Organization
Korea: Food and Drug Administration
Mexico: Federal Commission for Protection Against Health Risks
Philippines: Bureau of Food and Drugs
Russia: Ministry of Health of the Russian Federation
Ukraine: State Pharmacological Center - Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014