EUCTR2020-000435-45-AT进行中（未招募）1 期
A randomised, double-blind, placebo controlled, parallel group, multi-centre trial in adult subjects with newly diagnosed type 1 diabetes mellitus investigating the effect of Verapamil SR on preservation of beta-cell function (Ver-A-T1D)
Medical University of Graz0 个研究点目标入组 120 人开始时间: 2021年1月8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
- 120
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
- •Have given written informed consent
- •Age =18 and <45 years at consent
- •Must have a diagnosis of T1D of within 6 weeks duration at screening (from date of the first insulin injection)
- •Must have at least one or more diabetes-related autoantibodies present at screening
- •Must have random C-peptide levels =200 pmol/L measured at screening
- •Be willing to comply with intensive diabetes management
- •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 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria:
- •1.Be immunodeficient or have clinically significant chronic lymphopenia: Leukopenia (< 3,000 leukocytes /µL), neutropenia (<1,500 neutrophils/µL), lymphopenia (<800 lymphocytes/µL), or thrombocytopenia (<100,000 platelets/µL)
- •2.Have active signs or symptoms of acute infection at the time of screening
- •3.Be currently pregnant or lactating, or anticipate getting pregnant during the 12 months study period
- •4.Require use of immunosuppressive agents including chronic use of systemic steroids
- •5.Have evidence of current or past human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection
- •6.Have any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct, or cause increased risk to include pre-existing cardiac disease, chronic obstructive pulmonary disease (COPD), sickle cell disease, neurological, or blood count abnormalities, as judged by the investigator
- •7.Have persistent history of malignancies other than skin
- •8.History of liver insufficiency or laboratory evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal
- •9.History of renal insufficiency or evidence of renal dysfunction with creatinine greater than 1.5 times the upper limit of normal
- •10.Current or ongoing use of non-insulin pharmaceuticals that affect glycaemic control within prior 7 days of screening
- •11.Use of any other investigational drug in the previous 30 days and/or intent on using any investigational drug for the duration of the trial
- •12.Current use of Verapamil or other calcium channel blockers
- •13.Known hypersensitivity to Verapamil or to any of its excipients
- •14.Concomitant medication known for significantly inducing or inhibiting CYP3A4 and/or glycoprotein-P metabolism
- •15.Intake of grapefruit juice, licorice, St.John’s Wort, cannabidiol, ginkgo biloba
- •16.Substrate intake of CYP3A4 and/or glycoprotein-P metabolism, as judged by the investigator
- •17.Hypotension (of less than 100mmHg systolic), sick sinus syndrome (except patients with a functioning artificial pacemaker), uncompensated heart failure or severe left ventricular dysfunction; marked bradycardia (less than 50 beats/minute), atrial flutter or atrial fibrillation in the presence of an accessory bypass tract (e.g. Wolff-Parkinson-White syndrome), hypertrophic cardiomyopathy, acute myocardial infarction, attenuated neuromuscular transmission (e.g. by myasthenia gravis, Lambert-Eaton syndrome, advanced Duchenne muscular dystrophy)
- •18.ECG second or third degree atrioventricular block; Incomplete branch block.
- •19.Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results.
- •20.Current use of ß-blockers.
研究者
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