A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00528879
First received: September 11, 2007
Last updated: September 10, 2010
Last verified: May 2010

September 11, 2007
September 10, 2010
September 2007
November 2008   (final data collection date for primary outcome measure)
Change from baseline in hemoglobin A1C [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]
Change from baseline in hemoglobin A1C [ Time Frame: at Week 24 ]
Complete list of historical versions of study NCT00528879 on ClinicalTrials.gov Archive Site
  • Change from baseline in fasting plasma glucose [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving a therapeutic glycemic response, defined as AIC < 7.0% [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving a therapeutic glycemic response, defined as AIC ≤ 6.5% [ 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 fasting plasma glucose [ Time Frame: at Week 1 ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose [ Time Frame: at Week 24 ]
  • Proportion of subjects achieving a therapeutic glycemic response, defined as AIC < 7.0% [ Time Frame: at Week 24 ]
  • Change from baseline in total body weight [ Time Frame: at Week 24 ]
  • Change from baseline in fasting plasma glucose [ Time Frame: at Week 1 ]
Not Provided
Not Provided
 
A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on metformin alone. The safety of this treatment will also be studied.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Dapagliflozin
    Tablets, Oral, once daily, Up to 102 weeks
    Other Name: BMS-512148
  • Drug: placebo
    Tablets, Oral, once daily, Up to 102 weeks
  • Experimental: Arm 1
    2.5 mg
    Intervention: Drug: Dapagliflozin
  • Experimental: Arm 2
    5 mg
    Intervention: Drug: Dapagliflozin
  • Experimental: Arm 3
    10 mg
    Intervention: Drug: Dapagliflozin
  • Placebo Comparator: Arm 4
    0 mg
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
546
May 2010
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females, 18 to 77 years old, with type 2 diabetes and with inadequate glycemic control
  • Subjects who have been receiving metformin at a total daily dose ≥ 1500 mg/day for at least 8 weeks
  • C-peptide ≥ 1.0 ng/mL
  • Body Mass Index ≤ 45.0 kg/m2\
  • 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
  • Serum total bilirubin > 2 mg/dL
  • Creatinine kinase > 3 times the upper limit of normal
  • Symptoms of severely uncontrolled diabetes
  • Serum creatinine ≥ 1.50 mg/dL (133 µmol/L) for men or ≥ 1.40 mg/dL for women (124 µmol/L)
  • Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Both
18 Years to 77 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Brazil,   Canada,   Mexico
 
NCT00528879
MB102-014
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
AstraZeneca
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP