Phase 3
Completed N=182
Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00855166 ↗Enrolled (actual)
182
Serious AEs
3.9%
Results posted
Oct 2013
Primary outcomePrimary: Adjusted Mean Change in Total Body Weight — -0.88; -2.96 kg — p=<0.0001
Summary
This study is being carried out to see if dapagliflozin in addition to metformin decreases body weight and if so, how it compares with metformin alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change in Total Body Weight |
-0.88; -2.96 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in Waist Circumference |
-0.99; -2.51 | 0.0143 sig |
| SECONDARY Adjusted Mean Change in Body Fat Mass |
-0.74; -2.22 | 0.0001 sig |
| SECONDARY Proportion of Participants With Body Weight Decrease ≥5% |
4.3; 30.6 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes
- Ongoing treatment with metformin on a stable dose of ≥1500 mg/day for at least 12 weeks prior to enrolment
- Inadequate glycemic control, defined as HbA1c ≥6.5% and ≤8.5%
- ≥30 years for males
- ≥55 years for females
Exclusion Criteria
- Type 1 Diabetes
- Body weight change >5% within 3 months prior to enrolment
- Renal and liver impairment
Data sourced from ClinicalTrials.gov (NCT00855166). 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. Informational only — not medical advice.