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 - DECLARE

AstraZeneca AB0 sites17,150 target enrollmentOctober 2, 2013

ConditionsType II Diabetes mellitus MedDRA version: 19.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentSystem Organ Class: 100000004861 Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

DrugsForxiga

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Type II Diabetes mellitus
Sponsor: AstraZeneca AB
Enrollment: 17150
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 2, 2013

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

AstraZeneca AB

Eligibility Criteria

Inclusion Criteria

•For inclusion in the study patients should fulfill the following criteria:
•1\. Provision of informed consent prior to any study specific procedures (including run\-in)
•2\. Female or male aged \= 40 years
•3\. Diagnosed with T2DM (See Appendix E for details)
•4\. 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)
•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

Exclusion Criteria

•1\. 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
•2\. 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
•3\. 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\)
•4\. Diagnosis of Type 1 diabetes mellitus, MODY, or secondary diabetes mellitus
•5\. History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
•6\. History of any other malignancy within 5 years (with the exception of successfully treated non\-melanoma skin cancers)
•7\. Chronic cystitis and/or recurrent urinary tract infections (3 or more in the last year)
•8\. Any conditions that, in the opinion of the Investigator, may render the patient unable to complete the study including but not limited to cardiovascular (NYHA class IV CHF, recurrent ventricular arrhythmias) or non\-cardiovascular disease (e.g., active malignancy with the exception of basal cell carcinoma, cirrhosis, chronic lung disease, severe autoimmune disease) and/or a likely fatal outcome within 5 years
•9\. Pregnant or breast\-feeding patients