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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: April 18, 2008
Last updated: March 20, 2015
Last verified: March 2015
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
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:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The change in glycosylated hemoglobin (A1C) [ Time Frame: after 24 weeks ]

Secondary Outcome Measures:
  • The change in estimated glomerular filtration rate (marker of kidney function) [ Time Frame: after 52 weeks ]
  • The change in estimated creatinine clearance (marker of kidney function) [ Time Frame: after 52 weeks ]
  • The change in fasting plasma glucose [ Time Frame: after 24 weeks ]
  • The change in body weight [ Time Frame: after 24 weeks ]

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00663260

  Show 96 Study Locations
Sponsors and Collaborators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT00663260     History of Changes
Other Study ID Numbers: MB102-029 
Study First Received: April 18, 2008
Last Updated: March 20, 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases processed this record on January 19, 2017