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

AstraZeneca3 sites in 1 country116 target enrollmentApril 2009

ConditionsType 2 Diabetes Mellitus

InterventionsDapagliflozin Placebo

DrugsDapagliflozin Placebo

Overview

Phase: Phase 2
Intervention: Dapagliflozin
Conditions: Type 2 Diabetes Mellitus
Sponsor: AstraZeneca
Enrollment: 116
Locations: 3
Primary Endpoint: Adjusted Mean Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF])
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

August 2010

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Dapagliflozin

Intervention: Dapagliflozin

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Adjusted Mean Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF])

Time Frame: 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.