EUCTR2017-001454-33-ES进行中（未招募）1 期
A randomized, non-blinded, 24-week pilot study to evaluate the effect of dapagliflozin (10 mg once daily) plus exenatide (2.0 mg once weekly) on type 2 diabetic patients awaiting for bariatric surgery. DEXBASU study - DEXBAS
Dr. Albert Lecube Torello0 个研究点开始时间: 2017年6月22日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •1Male or female subjects aged between 18 and 60 years.
- •2BMI of = 35.0 - = 42.5 Kg/m2.
- •3Type-2 diabetes mellitus
- •4HbA1c = 7.0 - = 10.0%.
- •5Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements
- •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 56
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1Known type-1 diabetes or LADA diabetes
- •2Medication-induced obesity: Glucocorticoid and antipsychothic therapies
- •3Patients with a change of =5% of their reported body weight reported change within the previous 3 months.
- •4Previous surgical obesity treatment
- •5Use of approved weight lowering pharmacotherapy
- •6Active treatment with GLP-1RA
- •7Active treatment with SGLT2i
- •8Current drug or alcohol abuse
- •9Uncontrolled psychiatric illness
- •10History of acute or chronic pancreatitis, cholelithiasis, personal or familial history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2, or recurrent genital infections
- •11An estimated Glomerular Filtration Rate < 60 ml/min, calculated with the Modifications of Diet Renal Disease (MDRD-4) formula.
- •12Inadequate liver function as shown by: Serum or plasma ALT and AST > 2.5 x ULN; Serum or plasma total bilirubin >3 x ULN
- •13Major medical conditions (i) vascular disease within 3 months prior to signing the consent at visit 1: myocardial infarction, cardiac surgery or revascularization, unstable angina, heart failure, any significant cerebrovascular disesase; (ii) significant hepatic disease, including but not limited to chronic active hepatitis and/or severe hepatic insufficiency; (iii) history of hemoglobinopathy; and (iv) malignancy within 5 years of enrollment visit (with exception of treated basal cell or treated squamous cell carcionoma).
- •14Recurrent urinary tract or genital infections
- •15Active treatment with warfarin
- •16Pregnant women
- •17Women of childbearing potential (those who are not surgically sterilized or postmenopausal for at least 2 years) who do not agree to abstain from sexual intercourse with a male partner or use a medically acceptable method of birth control (such as condom, diaphragm or cervical/vault cap with spermicide) until 28 days post-treatment.
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