Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Dapagliflozin (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
Summary
The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Insulin sensitivity as measured by glucose disposal rate using the hyperinsulinemic euglycemic clamp method
Secondary outcome: Insulin secretion as measured by the acute insulin response to glucose using the frequently-sampled intravenous glucose tolerance test method
Eligibility
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Va San Diego Healthcare System, San Diego, California 92161, United States
Pennington Biomedical Research Center, Baton Rouge, Louisiana 70808, United States
Temple University General Clinical Research Center, Philadelphia, Pennsylvania 19140, United States
Additional Information
BMS Clinical Trials Disclosure Investigator Inquiry form For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Starting date: April 2009
Last updated: March 20, 2015
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