Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Collaborator:
AstraZeneca
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00831779
First received: January 28, 2009
Last updated: February 22, 2011
Last verified: October 2010
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Purpose
The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus |
Drug: Dapagliflozin Drug: Placebo |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Trial to Evaluate the Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Insulin sensitivity as measured by glucose disposal rate using the hyperinsulinemic euglycemic clamp method [ Time Frame: After 12 weeks of double-blind oral administration ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Insulin secretion as measured by the acute insulin response to glucose using the frequently-sampled intravenous glucose tolerance test method [ Time Frame: After 12 weeks of double-blind oral administration ] [ Designated as safety issue: No ]
Enrollment: | 44 |
Study Start Date: | April 2009 |
Study Completion Date: | August 2010 |
Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Dapagliflozin |
Drug: Dapagliflozin
Tablets, Oral, 5 mg, once daily, 12 weeks
Other Name: BMS-512148
|
Placebo Comparator: Placebo |
Drug: Placebo
Tablets, Oral, 0 mg, Once daily, 12 weeks
|
Eligibility
Ages Eligible for Study: | 35 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects with type 2 diabetes and inadequate glycemic control, defined as A1C ≥ 7.0 and ≤ 10.0% at the enrollment visit
- Subjects should have been receiving either metformin therapy OR metformin therapy AND one insulin secretagogue for at least 12 weeks prior to enrollment
- C-peptide ≥ 1.0 ng/ml (0.34 nmol/l)
- BMI ≤ 45.0 kg/m2
Exclusion Criteria:
- Urine albumin to creatinine ratio (UACR) > 1,800 mg/g (203.4 mg/mmol/Cr)
- Aspartate Aminotransferase (AST) > 3X Upper limit of normal (ULN)
- Alanine aminotransferase (ALT) > 3X ULN
- Serum Total Bilirubin > 2 mg/dL (34.2 μmol/l)
- Serum Creatinine (Scr) ≥ 1.50 mg/dL (133 μmol/l) for men; SCr ≥ 1.40 mg/dL (124 μmol/l) for women
- 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: NCT00831779
Locations
United States, California | |
Va San Diego Healthcare System | |
San Diego, California, United States, 92161 | |
United States, Louisiana | |
Pennington Biomedical Research Center | |
Baton Rouge, Louisiana, United States, 70808 | |
United States, Pennsylvania | |
Temple University General Clinical Research Center | |
Philadelphia, Pennsylvania, United States, 19140 |
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 18, 2012
Additional Information:
No publications provided
Responsible Party: | Study Director, Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00831779 History of Changes |
Other Study ID Numbers: | MB102-045 |
Study First Received: | January 28, 2009 |
Last Updated: | February 22, 2011 |
Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 2 Insulin Resistance Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Hyperinsulinism Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 18, 2012