NL-OMON41714已完成4 期
A phase 4, monocenter, randomized, double-blind, comparator-controlled, parallel-group, mechanistic intervention trial to assess the effect of 8-week treatment with the dipeptidyl peptidase-4 inhibitor (DPP-4i) linagliptin versus the sulfonylurea (SU) derivative glimepiride on renal physiology and biomarkers in metformin-treated patients with type 2 diabetes mellitus (T2DM) - RENALIS: RENoprotection in diAbetes by LInagliptin versus Sulfonylurea
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
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
- •* Caucasian
- •* Male and Female (must be post-menopausal; no menses >1 year)
- •* Age: 35 - 75 years
- •* BMI: >25 kg/m2
- •* Type 2 diabetes mellitus (HbA1c: 6.5 - 9% DCCT or 48 - 75 mmol/mol IFCC) who are being treated with a stable dose of oral antihyperglycemic agents (metformin monotherapy or combination of metformin and low dose SU derivative) for at least 3 months prior to inclusion
- •* All patients with previously diagnosed hypertension should use a RAS-interfering agent (ACE-i / ARB) for at least 3 months
排除标准
- •* Current / chronic use of the following medication: thiazolidinediones, insulin, glucocorticoids, immune suppressants, antimicrobial agents or chemotherapeutics. Subjects on diuretics will only be excluded when these drugs (e.g. hydrochlorothiazide) cannot be stopped for the duration of the study
- •* Chronic use of NSAIDS will not be allowed, unless used as incidental medication (1-2 tablets) for non-chronic indications (i.e. sports injury, head-ache or back ache). However, no such drugs can be taken within a time-frame of 2 weeks prior to renal-testing
- •* Estimated Glomerular Filtration Rate <60 mL/min/1.73m2 (determined by the Modification of Diet in Renal Disease (MDRD) study equation)
- •* Pregnancy
- •* Frequent occurrence of (confirmed) hypoglycemia (plasma glucose *3.9 mmol/L)
- •* Current urinary tract infection and active nephritis
- •* Recent (<6 months) history of cardiovascular disease, including: acute coronary syndrome, chronic heart failure (New York Heart Association grade II-IV), stroke, transient ischemic neurologic disorder
- •* Complaints compatible with or established gastroparesis
- •* Active liver disease or a 3-fold elevation of liver enzymes (aspartate aminotransferase (AST) / alanine aminotransferase (ALT)) at screening
- •* History of or actual pancreatic disease
- •* History of or actual malignancy (except for basal cell carcinoma)
- •* History of or actual severe mental disease
- •* Substance abuse (alcohol: defined as >4 units/day)
- •* Allergy to any of the agents used in the study
- •* Individuals who are investigator site personnel, directly affiliated with the study, or are immediate (spouse, parent, child, or sibling, whether biological or legally adopted) family of investigator site personnel directly affiliated with the study
- •* Inability to understand the study protocol or give informed consent
研究者
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