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

Completed · Phase 3 · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT01031680

Run by

AstraZeneca

People needed

922

Starts

2010-02-01

Expected to finish

2012-12-01

Last updated by the study team

2013-10-29

Who can join

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

You may qualify if…

• Type 2 diabetes mellitus.
• Cardiovascular disease
• Hypertension

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 — Phoenix, Arizona, United States
• Research Site — Burbank, California, United States
• Research Site — Garden Grove, California, United States
• Research Site — Huntington Park, California, United States
• Research Site — Lancaster, California, United States
• Research Site — Salinas, California, United States
• Research Site — San Marino, California, United States
• Research Site — San Ramon, California, United States
• Research Site — Tustin, California, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Waterbury, Connecticut, United States
• Research Site — Clearwater, Florida, United States
• Research Site — Deerfield Beach, Florida, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Hollywood, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Port Charlotte, Florida, United States
• Research Site — Port Orange, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Winter Park, Florida, United States
• Research Site — Columbus, Georgia, United States
• Research Site — Decatur, Georgia, United States
• Research Site — Stone Mountain, Georgia, United States
• Research Site — Gulf Shores, Alabama, United States

Full record on ClinicalTrials.gov

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