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

Phase 2
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Placebo
Drug: Dapagliflozin
Registration Number
NCT00831779
Lead Sponsor
AstraZeneca
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
116
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlacebo-
DapagliflozinDapagliflozin-
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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.

Trial Locations

Locations (3)

Temple University General Clinical Research Center

🇺🇸

Philadelphia, Pennsylvania, United States

Va San Diego Healthcare System

🇺🇸

San Diego, California, United States

Pennington Biomedical Research Center

🇺🇸

Baton Rouge, Louisiana, United States

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