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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831779
• Other study ID #: MB102-045
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2009
• Last updated: March 20, 2015
• Start date: April 2009
• Est. completion date: August 2010

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Insulin Resistance
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Dapagliflozin
Tablets, Oral, 5 mg, once daily, 12 weeks
• Placebo
Tablets, Oral, 0 mg, Once daily, 12 weeks

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity as measured by glucose disposal rate using the hyperinsulinemic euglycemic clamp method		After 12 weeks of double-blind oral administration	No
Secondary	Insulin secretion as measured by the acute insulin response to glucose using the frequently-sampled intravenous glucose tolerance test method		After 12 weeks of double-blind oral administration	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form