Phase 2
N=44
Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 Diabetes
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00831779 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Adjusted Mean Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF]) — -9.99; 7.98 % Change of Baseline Insulin Sensitivity — p=0.0059
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dapagliflozin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Percent Change From Baseline in Insulin Sensitivity at Week 12 (Last Observation Carried Forward [LOCF]) |
-9.99; 7.98 | 0.0059 sig |
| SECONDARY Adjusted Mean Change From Baseline in Insulin Secretion at Week 12 (Last Observation Carried Forward [LOCF]) |
-12.73; 15.39 | 0.0598 |
Summary
The purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00831779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.