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Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00663260
First received: April 18, 2008
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Dapagliflozin
Drug: Placebo
 Phase 2
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, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase 2/3 Trial to Evaluate the Glycemic Efficacy, Renal Safety, Pharmacokinetics, and Pharmacodynamics of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The change in glycosylated hemoglobin (A1C) [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change in estimated glomerular filtration rate (marker of kidney function) [ Time Frame: after 52 weeks ] [ Designated as safety issue: No ]
  • The change in estimated creatinine clearance (marker of kidney function) [ Time Frame: after 52 weeks ] [ Designated as safety issue: No ]
  • The change in fasting plasma glucose [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]
  • The change in body weight [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 202
Study Start Date: June 2008
Study Completion Date: June 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dapagliflozin (10 mg) Drug: Dapagliflozin
Tablets, Oral, 10 mg, Once Daily, 104 weeks
Other Name: BMS-512148
Active Comparator: Dapagliflozin (5 mg) Drug: Dapagliflozin
Tablets, Oral, 5 mg, Once Daily, 104 weeks
Other Name: BMS-512148
Placebo Comparator: Placebo Drug: Placebo
Tablets, Oral, 0 mg, Once Daily, 104 weeks

Detailed Description:

All eligible subjects will receive a single-blind placebo medication during a 1-week lead-in period prior to randomization. All arms may include the addition of open label medication described (as needed for rescue based on protocol specific criteria). Rescue medication is defined as the addition of an approved, appropriate antihyperglycemic agent, except metformin, used according to conventional standards of care, to treat hyperglycemia, which may therefore allow the subject to remain in the trial

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, ≥18 years old, with type 2 diabetes and with inadequate glycemic control
  • Clinical diagnosis of moderate renal impairment

Exclusion Criteria:

  • AST and /or ALT > 3.0 times the upper limit of normal
  • Serum total bilirubin > 1.5 times ULN
  • Symptoms of severely uncontrolled diabetes
  • Currently unstable or serious cardiovascular, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663260

  Show 96 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
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

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00663260     History of Changes
Other Study ID Numbers: MB102-029
Study First Received: April 18, 2008
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Brazil: Ministry of Health
Brazil: National Health Surveillance Agency
Canada: Health Canada
Denmark: The Ministry of the Interior and Health
France: Ministry of Health
India: Central Drugs Standard Control Organization
India: Directorate General of Foreign Trade
India: Indian Council of Medical Research
Israel: Ministry of Health
Italy: Ministry of Health
Mexico: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Peru: Ministry of Health
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Singapore: Health Sciences Authority
South Africa: Department of Health
Spain: Ministry of Health and Consumption

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

ClinicalTrials.gov processed this record on May 16, 2013