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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Dapagliflozin (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

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

Clinical Details

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

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

Primary outcome: Insulin sensitivity as measured by glucose disposal rate using the hyperinsulinemic euglycemic clamp method

Secondary outcome: Insulin secretion as measured by the acute insulin response to glucose using the frequently-sampled intravenous glucose tolerance test method

Eligibility

Minimum age: 35 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Va San Diego Healthcare System, San Diego, California 92161, United States

Pennington Biomedical Research Center, Baton Rouge, Louisiana 70808, United States

Temple University General Clinical Research Center, Philadelphia, Pennsylvania 19140, United States

Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: April 2009
Last updated: March 20, 2015

Page last updated: August 23, 2015

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