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Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00736879
First received: August 15, 2008
Last updated: February 22, 2011
Last verified: February 2010
History of Changes
  Purpose

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 diet and exercise alone. The safety of this treatment will also be studied


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Dapagliflozin
Drug: Placebo
 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, Placebo Controlled, Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

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

Secondary Outcome Measures:
  • Change from baseline in: total body weight; FPG; 2-hour post liquid meal glucose and waist circumference [ Time Frame: at Wk 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving a therapeutic glycemic response, defined as AIC<7.0% [ Time Frame: at Wk 24 ] [ Designated as safety issue: No ]

Enrollment: 280
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dapagliflozin: 1 mg
 Drug: Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Other Name: BMS-512148
Experimental: 2
Dapagliflozin: 2.5 mg
 Drug: Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Other Name: BMS-512148
Experimental: 3
Dapagliflozin: 5 mg
 Drug: Dapagliflozin
Tablets, Oral, Once Daily, Up to 24 weeks
Other Name: BMS-512148
Placebo Comparator: 4
Placebo: 0 mg
 Drug: Placebo
Tablets, Oral, Once Daily, Up to 24 weeks

  Eligibility

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

Inclusion Criteria:

  • Male and females, ≥18 to ≤77 years old, with type 2 diabetes mellitus
  • Subjects must have central laboratory pre-randomization A1C ≥7.0 and ≤ 10.0%
  • C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
  • Body Mass Index ≤ 45 kg/m²
  • Must be able to perform self monitoring of blood glucose

Exclusion Criteria:

  • AST and/or ALT >3X upper limit of normal (ULN)
  • Serum Total bilirubin >2 mg/dL (34.2 µmol/L)
  • Creatinine kinase >3X ULN
  • Serum creatinine ≥1.50 mg/dL (133 µmol/L) for male subjects, ≥1.40 mg/dL (124 µmol/L) for female subjects
  • Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736879

  Show 62 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00736879     History of Changes
Other Study ID Numbers: MB102-032
Study First Received: August 15, 2008
Last Updated: February 22, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
India: Central Drugs Standard Control Organization
Mexico: Federal Commission for Protection Against Health Risks
South Africa: Department of Health
Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013