EUCTR2020-000435-45-DEActive, not recruitingPhase 1
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 sites120 target enrollmentStarted: November 20, 2020Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
- •Have active signs or symptoms of acute infection at the time of screening
- •Be currently pregnant or lactating, or anticipate getting pregnant during the 12 months study period
- •Require use of immunosuppressive agents including chronic use of systemic steroids
- •Have evidence of current or past human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection
- •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
- •Have a history of malignancies other than skin
- •Evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal
- •Evidence of renal dysfunction with creatinine greater than 1.5 times the upper limit of normal
- •Current or ongoing use of non-insulin pharmaceuticals that affect glycaemic control within prior 7 days of screening
- •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
- •Current use of verapamil or other calcium channel blockers
- •Known hypersensitivity to verapamil or to any of the excipients, use of beta-blockers in patients with poor ventricular function, concomitant ingestion of grapefruit juice, combination with ivabradine
- •Hypotension (of less than 90mmHg systolic), sick sinus syndrome (except in patients with a functioning artificial pacemaker); uncompensated heart failure; marked bradycardia (less than 50 beats/minute), Wolff-Parkinson-
- •White syndrome, acute myocardial infarction complicated by bradycardia, marked hypotension or left ventricular failure
- •ECG second or third degree atrioventricular block
- •Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results
Investigators
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