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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: January 28, 2009
Last updated: March 20, 2015
Last verified: March 2015
The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Dapagliflozin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Insulin sensitivity as measured by glucose disposal rate using the hyperinsulinemic euglycemic clamp method [ Time Frame: After 12 weeks of double-blind oral administration ]

Secondary Outcome Measures:
  • Insulin secretion as measured by the acute insulin response to glucose using the frequently-sampled intravenous glucose tolerance test method [ Time Frame: After 12 weeks of double-blind oral administration ]

Enrollment: 44
Study Start Date: April 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dapagliflozin Drug: Dapagliflozin
Tablets, Oral, 5 mg, once daily, 12 weeks
Other Name: BMS-512148
Placebo Comparator: Placebo Drug: Placebo
Tablets, Oral, 0 mg, Once daily, 12 weeks


Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00831779

United States, California
Va San Diego Healthcare System
San Diego, California, United States, 92161
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
United States, Pennsylvania
Temple University General Clinical Research Center
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00831779     History of Changes
Other Study ID Numbers: MB102-045 
Study First Received: January 28, 2009
Last Updated: March 20, 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on February 27, 2017