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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

January 28, 2009
March 24, 2017
April 2009
August 2010   (Final data collection date for primary outcome measure)
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.
Insulin sensitivity as measured by glucose disposal rate using the hyperinsulinemic euglycemic clamp method [ Time Frame: After 12 weeks of double-blind oral administration ]
Complete list of historical versions of study NCT00831779 on ClinicalTrials.gov Archive Site
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.
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 ]
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Not Provided
 
Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes
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
The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Dapagliflozin
    Tablets, Oral, 5 mg, once daily, 12 weeks
    Other Name: BMS-512148
  • Drug: Placebo
    Tablets, Oral, 0 mg, Once daily, 12 weeks
  • Experimental: Dapagliflozin
    Intervention: Drug: Dapagliflozin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
August 2010
August 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
35 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00831779
MB102-045
No
Not Provided
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Astra Zeneca, Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
AstraZeneca
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP