EUCTR2013-000239-28-PL
Active, not recruiting
Phase 1
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
ConditionsType 2 Diabetes mellitusMedDRA version: 20.0Level: SOCClassification code 10027433Term: Metabolism and nutrition disordersSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 20.0Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsForxiga
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes mellitus
- Sponsor
- AstraZeneca AB
- Enrollment
- 17150
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
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
- •\- 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
- •2\. Acute cardiovascular event\[e.g., acute coronary syndrome (ACS),
Outcomes
Primary Outcomes
Not specified
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Completed
Phase 3
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 Diabetescardiovasculair overlijden, myocard infarct en ischemische beroertecardiovascular diseasediabetes10012653NL-OMON45088Astra Zeneca400