DECLARE-TIMI58

Dapagliflozin Effect on Cardiovascular Events. 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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222423

Enrollment

17150

Registered

2014-03-13

Start date

2013-12-12

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Diabetes Mellitus, Non-Insulin-Dependen High Risk for Cardiovascular Event

Interventions

investigational material(s) Generic name etc : Dapagliflozin INN of investigational material : dapagliflozin Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investiga

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Provision of informed consent prior to any study specific procedures - 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
safety efficacy -	—

Secondary

Measure	Time frame
safety efficacy -	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026