Phase 3
Completed N=218
Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea
Type 2 Diabetes Mellitus · High HbA1c Level · Inadequate Glycaemic Control
Source: ClinicalTrials.gov NCT01392677 ↗
Enrolled (actual)
218
Serious AEs
3.2%
Results posted
Dec 2013
Primary outcomePrimary: Adjusted Mean Change From Baseline in HbA1c Levels — -0.17; -0.86 Percent — p=<0.0001
Summary
This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change From Baseline in HbA1c Levels |
-0.17; -0.86 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in FPG |
-0.78; -34.23 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Total Body Weight |
-0.58; -2.65 | <0.0001 sig |
| SECONDARY Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF) |
11.1; 31.8 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure |
-0.27; -4.04 | 0.025 sig |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus
- Men or women age ≥ 18 years old
- Stable dose combination of metformin and sulfonylurea
- HbA1c ≥7.7% and ≤11.0%
Exclusion Criteria
- Type 1 diabetes mellitus or diabetes insipidus
- Recent cardiovascular events
- Kidney or urological disorders
- Hepatic disorders
Data sourced from ClinicalTrials.gov (NCT01392677). 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.