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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
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 metformin alone. The safety of this treatment will also be studied.


Condition Intervention Phase
Type 2 Diabetes
 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 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

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 Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 546
Study Start Date: September 2007
Study Completion Date: May 2010
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
2.5 mg
 Drug: Dapagliflozin
Tablets, Oral, once daily, Up to 102 weeks
Other Name: BMS-512148
Experimental: Arm 2
5 mg
 Drug: Dapagliflozin
Tablets, Oral, once daily, Up to 102 weeks
Other Name: BMS-512148
Experimental: Arm 3
10 mg
 Drug: Dapagliflozin
Tablets, Oral, once daily, Up to 102 weeks
Other Name: BMS-512148
Placebo Comparator: Arm 4
0 mg
 Drug: placebo
Tablets, Oral, once daily, Up to 102 weeks

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528879

  Show 75 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
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 by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00528879     History of Changes
Other Study ID Numbers: MB102-014
Study First Received: September 11, 2007
Last Updated: September 10, 2010
Health Authority: United States: Food and Drug Administration
Argentina: Administración Nacional de Medicamentos Alimentos y Tecnología Médica
Brazil: Ministério da Saúde and Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency)
Canada: Health Canada
Mexico: Federal Commission for Protection Against Health Risks
Russia: Ministry of Public Health and Social Development of Russian Federation and Ethic Committee of Federal Supervision Service for Public Health and Social Affairs

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

ClinicalTrials.gov processed this record on May 21, 2013