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

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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

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

Trial contacts and locations

135

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Data sourced from clinicaltrials.gov

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