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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients With Type 2 Diabetes (DECLARE) - DECLARE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/08/004872

Enrollment

17150

Registered

2014-08-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Diabetes Mellitus, Non-Insulin-Dependent High Risk for Cardiovascular Event Health Condition 2: E115- Type 2 diabetes mellitus with circulatory complications

Interventions

Intervention1: Dapagliflozin: Taken orally for up to 6 years Control Intervention1: Placebo tablet: ??? Control Intervention2: Placebo: Taken orally for up to 6 years

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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 Time to All-cause mortality Body weight change from baselineTimepoint: 6 years	—

Countries

Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, France, Germany, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Philippines, Poland, Republic of Korea, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States of America, Viet Nam

Contacts

Public ContactMr Tapankumar Shah

AstraZeneca Pharma India Ltd.

tapankumar.shah@astrazeneca.com9535104975

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026