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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):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00663260
First received: April 18, 2008
Last updated: June 6, 2014
Last verified: June 2014

April 18, 2008
June 6, 2014
June 2008
December 2009   (final data collection date for primary outcome measure)
The change in glycosylated hemoglobin (A1C) [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]
The change in glycosylated hemoglobin (A1C) [ Time Frame: after 24 weeks ]
Complete list of historical versions of study NCT00663260 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment
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

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

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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Dapagliflozin
    Tablets, Oral, 10 mg, Once Daily, 104 weeks
    Other Name: BMS-512148
  • Drug: Dapagliflozin
    Tablets, Oral, 5 mg, Once Daily, 104 weeks
    Other Name: BMS-512148
  • Drug: Placebo
    Tablets, Oral, 0 mg, Once Daily, 104 weeks
  • Active Comparator: Dapagliflozin (10 mg)
    Intervention: Drug: Dapagliflozin
  • Active Comparator: Dapagliflozin (5 mg)
    Intervention: Drug: Dapagliflozin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Kohan DE, Fioretto P, Tang W, List JF. Long-term study of patients with type 2 diabetes and moderate renal impairment shows that dapagliflozin reduces weight and blood pressure but does not improve glycemic control. Kidney Int. 2014 Apr;85(4):962-71. doi: 10.1038/ki.2013.356. Epub 2013 Sep 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
202
June 2011
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Canada,   Denmark,   France,   India,   Italy,   Mexico,   Peru,   Puerto Rico,   Singapore,   Spain
 
NCT00663260
MB102-029
Yes
AstraZeneca
AstraZeneca
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP