Phase 3
Completed N=922
Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and Hypertension
Source: ClinicalTrials.gov NCT01031680 ↗Enrolled (actual)
922
Serious AEs
5.8%
Results posted
Aug 2013
Primary outcomePrimary: Adjusted Mean Change in HbA1c Levels — -0.38; 0.08 Percent — p=<0.0001
Summary
This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight and blood pressure, when added to patients 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, cardiovascular disease and hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change in HbA1c Levels |
-0.38; 0.08 | <0.0001 sig |
| PRIMARY Proportion of Responders Meeting All Criteria of a 3-item Endpoint of Clinical Benefit |
11.7; 0.9 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) |
-2.96; -0.99 | 0.0126 sig |
| SECONDARY Adjusted Mean Percent Change in Body Weight |
-2.56; -0.30 | <0.0001 sig |
| SECONDARY Adjusted Mean Change in Seated Systolic Blood Pressure (SBP) at Week 24 (LOCF) |
-2.99; -1.03 | 0.0174 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 |
16.5; 4.0 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus.
- Cardiovascular disease
- Hypertension
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 (NCT01031680). 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.