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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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

• 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

• 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