EUCTR2013-000239-28-PL进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 17,150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •- Hypertension
- •- Current Tobacco use
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 9300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8575
排除标准
- •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),
- •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
- •4. Diagnosis of Type 1 diabetes mellitus, MODY, or secondary diabetes
- •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
- •Patients will be excluded during run-in and should not be randomized if
- •the following are observed from laboratory or observation during
- •enrollment and run-in assessments:
- •10. HbA1c =12% or HbA1c<6.5% from the central laboratory (nb, the
- •proportion of subjects with an HbA1c between 6.5 % and < 7.0 % will be
- •capped at approximately 5 % of the study)
- •11. AST or ALT >3x ULN or Total bilirubin >2.5 x ULN
- •12. CrCl < 60 ml/min (based on the Cockroft-Gault equation)
研究者
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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 beroerte10012653diabetescardiovascular diseaseNL-OMON45088Astra Zeneca400