EUCTR2014-002178-35-NL进行中（未招募）1 期
A phase 4, monocenter, randomized, open label, comparator-controlled, parallel-group, mechanistic intervention trial to assess the effect of 8-week treatment with the glucagon-like peptide-1 receptor agonist lixisenatide versus insulin glulisine on renal physiology and biomarkers in insulin glargine-treated patients with type 2 diabetes mellitus - ELIXIRS: Effect of LIXIsenatide on the Renal System
VU University Medical Center0 个研究点目标入组 40 人开始时间: 2014年8月5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
- 40
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
入选标准
- •Type 2 diabetes mellitus
- •Both genders (females must be post-menopausal; no menses >1 year)
- •Age: 35 - 75 years
- •BMI: 25 - 40 kg/m2
- •HbA1c: 6.5 - 10% DCCT (48 - 86 mmol/mol International Federation of Clinical Chemistry)
- •Stable treatment with basal insulin glargine and metformin or basal insulin glargine alone
- •Fasting plasma glucose (FPG) <10 mmol/L or the use of >50 units of basal insulin glargine
- •Hypertension should be under control, i.e. <140/90 mmHg, and treated with a RAAS-interfering agent (ACE-I or ARB) 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
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Current/chronic use of the following medication: TZD, SU derivative, GLP-1RA, DPP-4I, 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.
- •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
- •Hypoglycemia unawareness based on investigator judgment
- •History of severe hypoglycemia that required emergency hospital treatment within 3 months prior to screening
- •Estimated GFR <60 mL/min/1.73m2 (determined by the Modification of Diet in Renal Disease (MDRD) study equation)
- •Current urinary tract infection and active nephritis
- •Recent (<6 months) history of cardiovascular disease, including:
- •oAcute coronary syndrome
- •oChronic heart failure (New York Heart Association grade II-IV)
- •oStroke or transient ischemic neurologic disorder
- •Current atrial fibrillation
- •Complaints compatible with or established gastroparesis, neurogenic bladder and/or incomplete bladder emptying (as determined by ultrasonic bladder scan)
- •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
- •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 (i.e. GLP-1RA, inulin, metacresol (component lixisenatide and insulin glulisine), PAH, latex (component of PAH vial stopper))
- •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
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