Phase 3
Completed N=814
Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients
Source: ClinicalTrials.gov NCT00660907 ↗Enrolled (actual)
814
Serious AEs
10.0%
Results posted
Aug 2013
Primary outcomePrimary: Adjusted Mean Change in HbA1c Levels — -0.52; -0.52 percent — p=<0.0001
Summary
This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change in HbA1c Levels |
-0.52; -0.52 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in Body Weight |
-3.22; 1.44 | <0.0001 sig |
| SECONDARY Proportion of Participants With at Least One Episode of Hypoglycemia |
3.5; 40.8 | <0.0001 sig |
| SECONDARY Proportion of Participants With Body Weight Reduction of at Least 5% |
33.3; 2.5 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Type 2 Diabetes
- Treated with oral anti-diabetic drug therapy therapy including Metformin for at least 8 weeks prior to enrolment
- HbA1c >6.5% and </=10%
Exclusion Criteria
- Type 1 Diabetes
- Insulin therapy within one year of enrolment
- Renal (kidney) failure or dysfunction
Data sourced from ClinicalTrials.gov (NCT00660907). 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.