EUCTR2017-001547-12-NL进行中（未招募）1 期
A phase 4, monocenter, randomized, double-blind, comparator-controlled, 3-armed parallel mechanistic intervention trial to assess the effect of 8-week empagliflozin (SGLT-2 inhibitor) monotherapy, followed by 8-week empagliflozin and linagliptin (DPP-4 inhibitor) combination therapy versus 8-week linagliptin monotherapy, followed by 8-week linagliptin and empagliflozin combination therapy versus 8-week gliclazide (Sulfonylurea derivate), followed by 8-week gliclazide intensification therapy on renal physiology and biomarkers in metformin-treated patients with type 2 diabetes mellitus - RACELINES: Renal Actions of Combined Empagliflozin and LINagliptin in type 2 diabetES
VU University Medical Center0 个研究点目标入组 66 人开始时间: 2017年11月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
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
- •Caucasian*
- •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: 35 - 75 years
- •BMI: >25 kg/m2
- •HbA1c: 7.0 – 9.5% Diabetes Control and Complications Trial (DCCT) or 53 - 80 mmol/mol International Federation of Clinical Chemistry (IFCC)
- •Treatment with a stable dose of metformin monotherapy for at least 3 months prior to inclusion
- •Hypertension should be controlled, i.e. =140/90 mmHg, and treated with an ACE-I or ARB (unless prevented by side effect) for at least 3 months.
- •Albuminuria should be treated with a RAAS-interfering agent (ACE-I or ARB) for at least 3 months.
- •Written informed consent
- •* In order to increase homogeneity
- •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 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •Estimated GFR <45 mL/min/1.73m2 (determined by the Modification of Diet in Renal Disease (MDRD) study equation)
- •Current urinary tract infection and active nephritis
- •History of unstable or rapidly progressing renal disease
- •Macroalbuminuria; defined as ACR of 300 mg/g.
- •Current/chronic use of the following medication: thiazolidinediones, sulfonylurea derivatives, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitor, oral glucocorticoids, immune suppressants, antimicrobial agents, chemotherapeutics, antipsychotics, tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MOAIs).
- •Patients on diuretics will only be excluded when these drugs cannot be stopped 3 months prior randomization and for the duration of the study.
- •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 drugs can be taken within a time-frame of 2 weeks prior to renal-testing
- •History of or actual severe mental disease
- •History of or actual severe somatic disease (e.g. systemic disease)
- •History of or actual malignancy (except basal cell carcinoma)
- •History of or actual pancreatic disease
- •(Unstable) thyroid disease
- •Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN)
- •Recent (<6 months) history of cardiovascular disease, including
- •oAcute coronary syndrome
- •oStroke or transient ischemic neurologic disorder or chronic heart failure (NYHA grade II-IV)
- •Complaints compatible with or established neurogenic bladder and/or incomplete bladder emptying (as determined by ultrasonic bladder scan)
- •Substance abuse (alcohol: defined as >3 units alcohol/day)
- •History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g., emergency room visit and/or hospitalization) within 1 month prior to the Screening visit.
- •Recent blood donation (< 6 months)
- •Allergy to any of the agents used in the study
- •Inability to understand the protocol and/or give informed consent
- •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
研究者
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