Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT04545151
Eligibility Criteria:
Inclusion Criteria:
* Have given written informed consent
* Age ≥18 and \<45 at consent
* Must have a diagnosis of T1D of within 6 weeks duration at screening (date of the first insulin injection)
* Must have at least one or more diabetes-related autoantibodies present at screening: GADA, IA-2A and/or ZnT8A
* Must have fasting C-peptide levels ≥100 pmol/L measured at screening
* Be willing to comply with intensive diabetes management
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
* 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
* History of renal insufficiency or 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 its excipients
* Concomitant medication known for significantly inducing or inhibiting CYP3A4 and/or glycoprotein-P metabolism
* Intake of grapefruit juice, licorice, St.John's Wort, cannabidiol, ginkgo biloba
* Substrate intake of CYP3A4 and/or glycoprotein-P metabolism, as judged by the investigator
* 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)
* ECG second or third degree atrioventricular block; Incomplete branch block
* Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results
* Current use of ß-blockers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04545151
Study Brief:
Protocol Section:
NCT04545151