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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 is currently recruiting participants.
Verified by Bristol-Myers Squibb, January 2009
Sponsored by: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00663260
  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 II
Phase III

MedlinePlus related topics: Diabetes
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment: 252
Study Start Date: June 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Dapagliflozin

Dapagliflozin - 10 mg

Tablets, Oral, Once Daily, 52 weeks
2: Experimental Drug: Dapagliflozin

Dapagliflozin - 5 mg

Tablets, Oral, Once Daily, 52 weeks
3: Placebo Comparator Drug: Placebo

Placebo - 5 mg or 10 mg

Tablets, Oral, Once Daily, 52 weeks

  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

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

  Show 113 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More 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

Responsible Party: Bristol-Myers Squibb ( Study Director )
Study ID Numbers: MB102-029
Study First Received: April 18, 2008
Last Updated: January 12, 2009
ClinicalTrials.gov Identifier: NCT00663260  
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

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
 Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009



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