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

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus, Cardiovascular Disease, Inadequate Glycaemic Control

In brief

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

Key facts

Study ID

NCT01042977

Run by

AstraZeneca

People needed

964

Starts

2010-03-01

Expected to finish

2012-12-01

Last updated by the study team

2014-02-17

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 diabetes mellitus.
• Cardiovascular disease
• Uninterrupted anti-diabetic treatment for at least 8 weeks before enrolment

You may not qualify if…

• 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

Where it is running

• Research Site — Scottsdale, Arizona, United States
• Research Site — Anaheim, California, United States
• Research Site — Bell Gardens, California, United States
• Research Site — Chino, California, United States
• Research Site — Chula Vista, California, United States
• Research Site — Huntington Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Mission Hills, California, United States
• Research Site — Redondo Beach, California, United States
• Research Site — Riverside, California, United States
• Research Site — Sacramento, California, United States
• Research Site — San Diego, California, United States
• Research Site — Torrance, California, United States
• Research Site — Aventura, Florida, United States
• Research Site — Boca Raton, Florida, United States
• Research Site — Bradenton, Florida, United States
• Research Site — Brooksville, Florida, United States
• Research Site — Clearwater, Florida, United States
• Research Site — Dania Beach, Florida, United States
• Research Site — Delray Beach, Florida, United States
• Research Site — New Smyrna Beach, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Springfield, Illinois, United States
• Research Site — Avon, Indiana, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.