EUCTR2012-003256-36-NL进行中（未招募）不适用
A phase IV, randomized, double-blind, placebo-controlled, parallel-group trial to assess the effect of 12-week treatment with the glucagon-like peptide-1 receptor agonist (GLP-1RA) liraglutide or dipeptidyl peptidase-4 inhibitor (DPP-4i) sitagliptin on the cardiovascular, renal and gastrointestinal system in insulin-naïve patients with type 2 diabetes (T2DM). - SAFEGUARD, Pleiotropic effects of incretin based therapies
VU University Medical Center0 个研究点开始时间: 2012年11月2日最近更新:
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试验速览
- 阶段
- 不适用
- 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
- •- Both genders
- •-Age between 35 and 70 years. Females must be post-menopausal (no menses >1 year).
- •-Type 2 diabetes (HbA1c 6.5-9% DCCT or 48-75 mmol/mol IFCC), who are being treated with a stable dose of oral antihyperglycemic agents (either metformin alone, SU alone or a combination of metformin and SU) for at least 3 months prior to inclusion.
- •-BMI 25 - 40 kg/m2
- •- Caucasian
- •For the preceding pilot-study:
- •- Age between 18 and 50 years
- •- BMI 25 – 40 kg/m2
- •- Caucasian
- •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 43
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •- GFR < 60 mL/min/1.73m2
- •- Current / chronic use of the following medication: thiazolidinediones, GLP-1RA, DPP-4i, glucocorticoids, NSAIDs, insulin, antimicrobial agents, chemotherapeutics or immune suppressants. Subjects on diuretics will only be excluded when these drugs (e.g. hydrochlorothiazide) cannot be stopped for the duration of the study.
- •- History of or actual pancreatic disease or impaired pancreatic exocrine function (defined as needed use of pancreatic enzymes)
- •- Active liver disease or a 3-fold elevation of liver enzymes (AST / ALT) at screening
- •- History of or actual malignancy (with the exception of basal cell carcinoma)
- •- Current urinary tract infection and active nephritis
- •-Recent (<6 months) history of cardiovascular disease, including acute coronary syndrome, stroke, transient ischemic neurologic disorder or chronic heart failure (New York Heart Association grade II-IV)
- •- Current atrial fibrillation
- •- Chronic infectious or auto-immune disease
- •- Substance and/or alcohol abuse, defined as >4 units alcohol/day (because of risk of pancreatitis)
- •- History of allergy/hypersensitivity to GLP-1RA, DPP-4i, inulin, para-aminohippuric acid, acetaminophen, secretin, MRI contrast agent or latex (component of PAH).
- •- Complaints compatible with or established gastroparesis and/or neurogenic bladder
- •- Any condition that has been recognized as a contra-indication for the use of GLP-1RA and DPP-4i, as listed in the respective SPCs
- •- History of or actual (severe) mental illness
- •- Inability to understand the study protocol and/or inability to give informed consent
- •- History of claustrophobia or presence of metal objects/implants (because of MRI protocol)
- •For the preceding pilot-study:
- •Similar to the exclusion criteria for the main study, with the additions of:
- •- Subjects with a fasting plasma glucose =5.6 mmol/L, a 2-hour glucose of =7.8 mmol/L after a 75-grams oral glucose tolerance test, or a HbA1c of =6.5%
- •- Subjects using any kind of medication
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