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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Inadequate Glycaemic Control; Type 2 Diabetes Mellitus; Cardiovascular Disease

Treatments: Drug: Dapagliflozin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01042977

D1690C00019

Details and patient eligibility

About

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

Enrollment: 964 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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964 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

dapagliflozin 10 mg tablet

Treatment:

Drug: Dapagliflozin

2

Placebo Comparator group

Description:

matching placebo tablet

Treatment:

Drug: Placebo