Phase 3
Completed N=965
Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular Disease
Type 2 Diabetes Mellitus · Cardiovascular Disease · Inadequate Glycaemic Control
Source: ClinicalTrials.gov NCT01042977 ↗
Enrolled (actual)
965
Serious AEs
9.0%
Results posted
Aug 2013
Primary outcomePrimary: Adjusted Mean Change in HbA1c Levels — -0.33; 0.07 Percent — p=<0.0001
Summary
This study is carried out to assess whether dapagliflozin improves glycemic control, decreases fasting plasma glucose levels, body weight and blood pressure when added to patient's existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes and cardiovascular disease
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change in HbA1c Levels |
-0.33; 0.07 | <0.0001 sig |
| PRIMARY Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit |
10.0; 1.9 | <0.0001 sig |
| SECONDARY Adjusted Mean Percent Change in Body Weight |
-2.53; -0.61 | <0.0001 sig |
| SECONDARY Proportion of Participants With a Reduction From Baseline of 5% or More in Body Weight in Participants With Baseline BMI ≥27 kg/m² |
18.4; 4.8 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in Systolic Blood Pressure at Week 8 (LOCF) |
-1.85; 0.86 | 0.0007 sig |
| SECONDARY Adjusted Mean Change in Seated Systolic Blood Pressure at Week 24 (LOCF) |
-2.70; 0.32 | 0.0002 sig |
| SECONDARY Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 8 (LOCF) in Participants With Baseline SBP>=130 mmHg |
-5.33; -1.89 | 0.0004 sig |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus.
- Cardiovascular disease
- Uninterrupted anti-diabetic treatment for at least 8 weeks before enrolment
Exclusion Criteria
- Patients with type 1 diabetes or diabetes insipidus
- Patients with 3 or more oral anti-hyperglycaemic drugs with or without insulin and/or poorly controlled diabetes
- Any clinically significant illness, which would compromise the patient's safety and their participation in the study
Data sourced from ClinicalTrials.gov (NCT01042977). 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.