DECLARE -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
    Recruiting
Updated on 25 March 2021

Summary

DECLARE -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

Description

The primary efficacy objective is to determine whether treatment with dapagliflozin compared with placebo when added to current background therapy will result in a reduction in the incidence of the composite endpoint of cardiovascular death, myocardial infarction (MI), or ischemic stroke in patients with type 2 diabetes mellitus (T2DM) with either established cardiovascular disease or at least two cardiovascular risk factors in addition to T2DM.

Details
Clinical Study IdentifierTX137614
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Provision of informed consent prior to any study specific procedures (including run-in)
Female or male aged ≥ 40 years
Diagnosed with T2DM (See Appendix E for details)
High Risk for CV event defined as having either established CV disease and/or multiple risk factors
Established CV Disease (See Appendix E for details) OR
No known cardiovascular disease AND at least two cardiovascular risk factors in addition to T2DM, defined as
Age > 55 years in men and > 60 in women
AND presence of at least 1 of the following additional risk factors (see Appendix E for details)
Dyslipidemia
Hypertension
Current Tobacco use
AND OTHERS

Exclusion Criteria

Use of the following excluded medications
Current or recent (within 24 months) treatment with pioglitazone and/or use of pioglitazone for a total of 2 years or more during lifetime - Current or recent (within 12 months) treatment with rosiglitazone
Previous treatment with any SGLT2 inhibitor
Any patient currently receiving chronic (>30 consecutive days) treatment with an oral steroid at a dose equivalent to oral prednisolone ≥10 mg (e.g., betamethasone ≥1.2 mg, dexamethasone ≥1.5 mg, hydrocortisone ≥40 mg) per day
Acute cardiovascular event [e.g., acute coronary syndrome (ACS), transient ischemic attack (TIA), stroke, any revascularization, decompensated HF, sustained ventricular tachycardia <8 weeks prior to randomization. Patients with acute cardiovascular events can be enrolled in the run-in period as long as randomization does not occur within 8 weeks of the event
Systolic BP >180 or diastolic BP >100 mmHg at randomization. Patient should be excluded if either the systolic BP is elevated (> 180 mmHg) or the diastolic BP is elevated (> 100 mmHg) on both measurements (see section 6.4.8.1)
AND OTHERS
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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