Overview

Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and Hypertension

Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Collaborator:
Bristol-Myers Squibb
Treatments:
Dapagliflozin
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