Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events (DECLARE-TIMI 58) in Type II diabetes patients.

Phase 3

Active, not recruiting

• Conditions: Type 2 diabetes mellitus with circulatory complications,

• Registration Number: CTRI/2014/08/004872
• Lead Sponsor: AstraZeneca AB

Brief Summary

**This study is a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients with Type 2 Diabetes. Total duration of the study is up to 6 years. Total of 17150 subjects will be randomized globally from approximately 1000 sites from 33 countries. The primary outcome measures will be time to first event included in the composite endpoint of CV death, MI or ischemic stroke for a period of up to 6 years.And secondary outcome measures will be:· Time to first event of Hospitalization for Congestive Heart Failure for a period of up to 6 years,· Time to first event included in the composite endpoint of CV death, MI, ischemic stroke, hospitalization for heart failure, hospitalization for unstable angina pectoris, or hospitalization for any revascularization for a period of up to 6 years,· Time to all-cause mortality for a period of up to 6 years, and Body weight change from baseline for a period of up to 6 years.**

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-16
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 17150

Inclusion Criteria

• Provision of informed consent prior to any study specific procedures • Female or male aged more than or equal to 40 years and less or equal 65 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: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first event included in the composite endpoint of CV death, MI or ischemic stroke [ Time Frame: up to 6 years ]	Time to first event included in the composite endpoint of CV death, MI or ischemic stroke [ Time Frame: up to 6 years ]

Secondary Outcome Measures

Name	Time	Method
Time to first event of Hospitalization for Congestive Heart Failure	Time to first event included in the composite endpoint of CV death, MI, ischemic stroke, hospitalization for heart failure, hospitalization for unstable angina pectoris, or hospitalization for any revascularization

Trial Locations

Locations (5)

Care Institute of Medical Sciences; 🇮🇳 Ahmadabad, GUJARAT, India

Christian Medical College MC; 🇮🇳 Vellore, TAMIL NADU, India

KEM Hospital; 🇮🇳 Pune, MAHARASHTRA, India

St. Johns Medical College and Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Victoria Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Care Institute of Medical Sciences

🇮🇳Ahmadabad, GUJARAT, India

Dr PS Iyengar

Principal investigator

00917927712771

ps.iyengar@cimshospital.org