NL-OMON46820已完成3 期
An open-label randomised cross-over study to evaluate the albuminuria lowering effect of dapagliflozin, exenatide and their combination in patients with type 2 diabetes - DECADE
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Type 2 diabetes
- •* HbA1c * 6.5% (48 mmol/mol)
- •* eGFR > 30 ml/min/1.73m2
- •* Albumin:creatinine ratio >3.5mg/mmol and *100 mg/mmol
- •* Age * 18 years
- •* Written informed consent
排除标准
- •* Pregnant women and women of child-bearing potential who are not using reliable contraception
- •* Cardiovascular disease: myocardial infarction, angina pectoris, percutanous transluminal coronary angioplasty, coronary artery bypass grafting, stroke, heart failure (NYHA I-IV) < 6 months before inclusion
- •* Uncontrolled blood pressure (> 160/ 100 mmHg)
- •* Active malignancy
- •* History of autonomic dysfunction (e.g. history of fainting or clinically significant orthostatic hypotension)
- •* Participation in any clinical investigation within 3 months prior to initial dosing.
- •* Donation or loss of 400 ml or more of blood within 8 weeks prior to initial dosing
- •* History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.
- •* Use of SGLT-2 inhibitor, GLP1-RA or DPP-4 inhibitor.
- •* Lithium use
- •* Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications
- •* Any condition when MRI is contraindicated
研究者
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