Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events

Phase 3

Completed

• Conditions: Diabetes Mellitus, Non-Insulin-Dependent; High Risk for Cardiovascular Event
• Interventions: Drug: Dapagliflozin 10 mg; Drug: Placebo tablet

• Registration Number: NCT01730534
• Lead Sponsor: AstraZeneca

Brief Summary

This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-15
• Study First Submitted QC: 2012-11-20
• Study First Posted: 2012-11-21
• Study Start: 2013-04-25
• Primary Completion: 2018-09-11
• Study Completion: 2018-09-11
• Results First Submitted: 2019-09-06
• Status Verified: 2019-11
• Results First Submitted QC: 2019-12-11
• Last Update Submitted: 2019-12-11
• Results First Posted: 2019-12-26
• Last Update Posted: 2019-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17190

Inclusion Criteria

• Provision of informed consent prior to any study specific procedures
• Female or male aged ≥40 years
• Diagnosed with Type 2 Diabetes
• High Risk for Cardiovascular events

Exclusion Criteria

• Diagnosis of Type 1 diabetes mellitus History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
• Chronic cystitis and/or recurrent urinary tract infections
• Pregnant or breast-feeding patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin	Dapagliflozin 10 mg	Dapagliflozin + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors
Placebo	Placebo tablet	Placebo + standard of care therapy for Type 2 Diabetes and for co-morbidities and cardiovascular risk factors

Primary Outcome Measures

Name	Time	Method
Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.	up to 5.2 years	Co-primary efficacy
Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke	up to 5.2 years	Safety and co-primary efficacy

Secondary Outcome Measures

Name	Time	Method
Subjects Included in the Renal Composite Endpoint: Confirmed Sustained ≥40% Decrease in eGFR to eGFR <60 ml/Min/1.73m2 and/or ESRD and/or Renal or CV Death.	up to 5.2 years	Secondary
Subjects Included in the Endpoint of All-cause Mortality.	up to 5.2 years	Secondary

Trial Locations

Locations (1)

Research Site; 🇻🇳 Ho Chi Minh City, Vietnam