NL-OMON48622已完成4 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 r - Renal Actions of Combined Empagliflozin and LINagliptin in type 2 diabetES
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 64（—）
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
- •* Treatment with a stable dose of oral antihyperglycemic agents for at least 3
- •months prior to inclusion
- •* Metformin monotherapy
- •* Combination of metformin and low-dose SU derivative
排除标准
- •Main study:
- •* Estimated GFR <45 mL/min/1.73m2 (determined by the Modification of Diet in
- •Renal Disease (MDRD) study equation)
- •* Hemoglobin level < 7.0 mmol/L
- •* Current urinary tract infection and/or 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
- •* Pregnancy
- •* 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
- •o Acute coronary syndrome
- •o Stroke 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
- •Exclusion criteria
- •* History of gout
- •* Current/chronic use of the following medication: diuretics, SGLT-2 inhibitor,
- •uric acid lowering medication, pyranizamide, vitamin K antagonists,
- •salicylates, thiazide diuretics.
- •* Estimated GFR <60 mL/min/1.73m2 (determined by the Modification of Diet in
- •Renal Disease (MDRD) study equation)
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