EUCTR2013-000239-28-NL进行中（未招募）1 期
DECLARE Dapagliflozin Effect on Cardiovascular EventsA 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
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
- •4. High Risk for CV event defined as having either established CV disease and/or multiple risk factors:
- •-Established CV Disease
- •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
- •-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 7850
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 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
- •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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