A Phase I/II Double-blind, randomized, placebo-controlled trial to preserve residual insulin secretion in children with recent onset Type 1 diabetes by giving oral Verapamil

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Linkopings Universitet

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hormonal diseases [C19], Diseases [C] - Immune System Diseases [C20]

Trial duration

6 Aug 2025 → ongoing

Decision date (initial)

2025-02-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the effect on preservation of residual beta cell function by treatment with Verapamil

Secondary objectives 1

1. To evaluate safety, but also clinical efficacy of Verapamil treatment such as blood glucose control and prevention of acute complications, and immunological effect on the disease process.

Conditions and MedDRA coding

Type 1 diabetes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Informed consent given by patients and caregivers/parents
2. Type 1 diabetes according to the ADA classification within the previous 3 months at the time of screening
3. Fasting C-peptide >0.12 nmol/ml
4. Elevated levels of any diabetes-related antibody/ies (e.g. GADA, IAA, IA-2A, ZnT8A) is/are present
5. • Age 4.00 - 9.99 years at Diagnosis of Type 1 diabetes

Exclusion criteria 2

1. Cardiac disease/problems, abnormal ECG, or history of abnormal blood pressure
2. Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. The primary endpoint for part A - Frequency of AE and SAE during the study period (from start of treatment to 18 months).
2. The primary endpoint for part B - Change in C-peptide (AUCmean 0-120 min) during an MMTT from baseline to month 24.

Secondary endpoints 9

1. The secondary endpoints for part A - Degree of metabolic control measured by HbA1c and TiT measured with Continuous Glucose Monitoring (CGM)
2. The secondary endpoints for part A-Insulin requirement measured as Insulin dose per kg body weight and 24 hours after 12 and 24 months
3. The secondary endpoints for part A - Preservation of residual beta cell function (C-peptide) measured by MMTT
4. The secondary endpoints for part B -Change in fasting C-peptide value during MMTT from baseline to month 24
5. The secondary endpoints for part B - Change in C-peptide 90 minute value during MMTT from baseline to month 24
6. The secondary endpoints for part B-Proportion of patients with peak C-peptide > 0.20 nmol/l at month 24.
7. The secondary endpoints for part B- Change in Hemoglobin A1c (HbA1c) between baseline and subsequent visits.
8. The secondary endpoints for part B-Change in exogenous insulin dose per kg body weight and 24 hours between baseline and subsequent visits when insulin doses are collected.
9. The secondary endpoints for part B-Frequency of Serious Adverse Events related to study treatment.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Linkopings Universitet

Sponsor organisation

Linkopings Universitet

Address

Sandbacksgatan 7, Linkopings Domkyrkofors. Linkopings Domkyrkofors.

City

Linkoping

Postcode

582 25

Country

Sweden

Scientific contact point

Organisation

Linkopings Universitet

Contact name

Johnny Ludvigsson

Public contact point

Organisation

Linkopings Universitet

Contact name

Johnny Ludvigsson

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications