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

This study has been completed.
Sponsor:
Collaborator:
Astra Zeneca, Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00831779
First received: January 28, 2009
Last updated: March 24, 2017
Last verified: March 2017
  Purpose
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: Participant, Care Provider, 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:
  • 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.


Secondary Outcome Measures:
  • Adjusted Mean Change From Baseline in Insulin Secretion 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.


Enrollment: 116
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

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00831779

Locations
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
AstraZeneca
Astra Zeneca, Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00831779     History of Changes
Other Study ID Numbers: MB102-045
Study First Received: January 28, 2009
Results First Received: September 30, 2016
Last Updated: March 24, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 19, 2017