Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04545151
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2020-08-21
Brief Title:
Verapamil SR in Adults With Type 1 Diabetes
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Ver-A-T1D
Brief 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 wwwinnodiaeu 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
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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-000435-45 | EUDRACT_NUMBER | None | None |