NL-OMON49031已完成4 期
A phase 4, monocenter, randomized, double-blind, placebo-controlled, 4-armed cross-over mechanistic intervention study to assess the renal hemodynamic effect of mono- and combination therapy with empagliflozin (SGLT-2 inhibitor) and losartan (RAS inhibitor) in metformin and/or SU-treated patients with type 2 diabetes mellitus - RECOLAR: Renohemodynamic Effects of Combined empagliflOzin and LosARtan
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
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, Asian or Middle Eastern (sub-Saharan patients are not eligible);
- •* Both genders (females must be post-menopausal; no menses >1 year; in case of
- •doubt, Follicle-Stimulating Hormone (FSH) will be determined with cut-off
- •defined as >31 U/L)
- •* Age: 45 - 80 years
- •* BMI: >25 kg/m2
- •* HbA1c: 6.5 * 10.5% Diabetes Control and Complications Trial (DCCT) or 48 - 91
- •mmol/mol International Federation of Clinical Chemistry (IFCC)
- •* Treatment with a stable dose of metformin and/or SU therapy for at least 3
- •months prior to inclusion
- •* Written informed consent
排除标准
- •* History of unstable or rapidly progressing renal disease
- •* Macroalbuminuria; defined as ACR of 300mg/g.
- •* Estimated GFR <60 mL/min/1.73m2 (determined by the Modification of Diet in
- •Renal Disease (CKD-EPI) study equation)
- •* Only use of alpha blockers and/or beta blockers are allowed as
- •antihypertensive background therapy. Patients using an antihypertensive agent
- •will be considered if this agent can be stopped (i.e. blood pressure adequate
- •to stop at screening) or replaced by an alpha or beta blocker. In these
- •patients, a 4 week wash-out/run-in period will be observed prior to visit 2.
- •* Current/chronic use of the following medication: SGLT2 inhibitors, RAS
- •inhibitors, TZD, GLP-1RA, DPP-4 inhibitors, glucocorticoids, immune
- •suppressants, antimicrobial agents, chemotherapeutics, antipsychotics,
- •tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs).
- •Subjects on diuretics will only be excluded when these drugs cannot be stopped
- •for the duration of the study.
- •* Volume depleted patients. Patients at risk for volume depletion due to
- •co-existing conditions or concomitant medications, such as loop diuretics
- •should have careful monitoring of their volume status.
- •* Chronic use of non-steroidal anti-inflammatory drugs (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 drug
- •can be taken within a time-frame of 2 weeks prior to renal-testing
- •* History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g.
- •emergency room visit and/or hospitalization) within 1 month prior to the
- •Screening visit.
- •* Current urinary tract infection and active nephritis
- •* Recent (<6 months) history of cardiovascular disease, including:
- •o Acute coronary syndrome
- •o Chronic heart failure (New York Heart Association grade II-IV)
- •o Stroke or transient ischemic neurologic disorder
- •* Complaints compatible with neurogenic bladder and/or incomplete bladder
- •emptying (as determined by ultrasonic bladder scan)
- •* Severe hepatic insufficiency and/or significant abnormal liver function
- •defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN)
- •and/or alanine aminotransferase (ALT) >3x ULN
- •* (Unstable) thyroid disease; defined as fT4 outside of laboratory reference
- •values or change in treatment within 3 months prior to screening visit
- •* History of or actual malignancy (except 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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