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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Dapagliflozin; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00831779

MB102-045

Details and patient eligibility

About

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

Enrollment: 116 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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116 participants in 2 patient groups, including a placebo group

Dapagliflozin

Experimental group

Treatment:

Drug: Dapagliflozin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo