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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2009

Intervention(s) in this Clinical Trial

• Drug: Dapagliflozin
  • Tablets, Oral, Once daily, 24 weeks
• Drug: Metformin XR
  • Tablets, Oral, Once daily, 24 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
  • Dapagliflozin (5 mg) + Metformin XR (up to 2000 mg)
• Experimental: Arm 2
  • Dapagliflozin (5 mg)
• Active Comparator: Arm 3
  • Metformin XR (500 mg up to 2000 mg)

Primary Measures

• Change from baseline in hemoglobin A1C
  • Time Frame: at Week 24
    Safety Issue?: No

Secondary 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
    Safety Issue?: No
• Proportion of subjects achieving a therapeutic glycemic response, defined as A1C < 7.0%
  • Time Frame: at Week 24
    Safety Issue?: No
• Change from baseline in total body weight
  • Time Frame: at Week 24
    Safety Issue?: No
• Change from baseline in A1C (A1C category ≥9.0%)
  • Time Frame: at Week 24
    Safety Issue?: No
• Change from baseline in total body weight (baseline BMI category ≥27 kg/m2)
  • Time Frame: at Week 24
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 77 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bristol-Myers Squibb

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00643851

Study ID Number: MB102-021

ClinicalTrials.gov Identifier: NCT00643851

Health Authority: United States: Food and Drug Administration

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