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

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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

Key facts

Study ID

NCT00831779

Run by

AstraZeneca

People needed

116

Starts

2009-04-01

Expected to finish

2010-08-01

Last updated by the study team

2017-04-24

Who can join

Age: 35 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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