Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes

Phase 2

Completed

Brief Summary: The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Dapagliflozin	Dapagliflozin	-

Primary Outcome Measures

Name	Time	Method
Adjusted Mean Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF])	From Baseline to Week 12	Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period.

Secondary Outcome Measures

Name	Time	Method
Adjusted Mean Change From Baseline in Insulin Secretion at Week 12 (Last Observation Carried Forward [LOCF])	From Baseline to Week 12	Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Measurements were obtained during the randomization visit and Week 12 in the double-blind period.

Locations (3): Va San Diego Healthcare System
🇺🇸
San Diego, California, United States
Pennington Biomedical Research Center
🇺🇸
Baton Rouge, Louisiana, United States
Temple University General Clinical Research Center
🇺🇸
Philadelphia, Pennsylvania, United States
Va San Diego Healthcare System
🇺🇸San Diego, California, United States