Verapamil SR in Adults With Type 1 Diabetes

Status Recruiting

Clinical Trial Summary

This study has been set up within the framework of the INNODIA network. INNODIA is a global partnership between 31 academic institutions, 6 industrial partners, a small sized enterprise and 2 patient organizations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". (www.innodia.eu) The overall aim of INNODIA is to advance in a decisive way how to predict, stage, evaluate and prevent the onset and progression of type 1 diabetes (T1D). For this, INNODIA has established a comprehensive and interdisciplinary network of clinical and basic scientists, who are leading experts in the field of T1D research in Europe and UK (United Kingdom), with complementary expertise from the areas of immunology, Beta-cell biology, biomarker research and T1D therapy, joining forces in a coordinated fashion with industry partners and two foundations, as well as with all major stakeholders in the process, including regulatory bodies and patients with T1D and their families.

Clinical Trial Description

The study is a multicenter, randomized, double-blind, placebo-controlled study in volunteers with newly diagnosed diabetes mellitus type 1 (within 6 weeks after diagnosis). The purpose of the clinical trial is to confirm the effect of 360mg Verapamil sustained release (SR) administered orally once daily (titrated over the first 3 months from 120 mg to 360 mg) on the preservation of beta-cell function measured as stimulated C-peptide after 12 months compared to placebo. The study has a cross-over design and a duration of approximately 24 months, consisting of 3 telephone visits and 7 visits at the trial site. The duration of the treatment phase with verapamil is 12 months, and an additional (optional) follow-up visit will be carried out 12 months after completion of the study. The study procedures are identical in all 20 clinical centres across Europe and the UK. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04545151
Study type	Interventional
Source	Medical University of Graz
Contact	Martina Brunner, MSc
Phone	+43 316 385
Email	martina.brunner@medunigraz.at
Status	Recruiting
Phase	Phase 2
Start date	February 8, 2021
Completion date	April 2026

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04030091` - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus	Phase 4
Terminated	`NCT03605329` - Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS	N/A
Completed	`NCT01696266` - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Recruiting	`NCT06050642` - Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.	N/A
Completed	`NCT05107544` - Metabolic, Physical Fitness and Mental Health Effects of High Intensity Interval Training (HIIT) in Adolescents With Type 1 Diabetes	N/A
Active, not recruiting	`NCT04443153` - Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes	N/A
Completed	`NCT04521634` - Glycaemic Variability in Acute Stroke
Completed	`NCT04569994` - A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes	Phase 1
Completed	`NCT04089462` - Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study	N/A
Completed	`NCT03143816` - Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study	Phase 4
Completed	`NCT01892319` - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Recruiting	`NCT04039763` - RT-CGM in Young Adults at Risk of DKA	N/A
Completed	`NCT04042207` - Diabeloop for Highly Unstable Type 1 Diabetes	N/A
Not yet recruiting	`NCT06068205` - COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
Recruiting	`NCT05909800` - Prolonged Remission Induced by Phenofibrate in Children Newly Diagnosed With Type 1 Diabetes.	Phase 2
Active, not recruiting	`NCT04974528` - Afrezza® INHALE-1 Study in Pediatrics	Phase 3
Completed	`NCT04530292` - Home Intervention and Social Precariousness in Childhood Diabetes	N/A
Completed	`NCT05428943` - OPT101 in Type 1 Diabetes Patients	Phase 1
Recruiting	`NCT03988764` - Monogenic Diabetes Misdiagnosed as Type 1
Completed	`NCT05597605` - The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Verapamil SR in Adults With Type 1 Diabetes — Ver-A-T1D

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms