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New treatment option for Type 1 Diabetes
Official title A Phase I/II Trial to Preserve Residual Insulin Secretion in Children With Recent Onset Type 1 Diabetes by Giving Verapamil
ClinicalTrials.gov ID: NCT07199946
What this study is testing
What is Verapamil (Part A)?
Verapamil (Part A) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for type 1 diabetes.
Also referred to as Isoptin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The objective of this trial is first to evaluate safety and then the effect on preservation of residual beta cell function also clinical efficacy by treatment with Verapamil in children with recent onset Type 1 diabetes. Patients are included with the following inclusion criteria; Informed consent given by patients and caregivers/parents Type 1 diabetes according to the ADA classification within the previous 3 months at the time of screening Age 4.00 -9.99 years at Diagnosis of Type 1 diabetes Fasting C-peptide \>0.12 nmol/ml Elevated levels of any diabetes-related antibody/ies (eg GADA, IAA, IA-2A, ZnT8A ) is/are present.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 9
You may be able to join if
- Informed consent given by patients and caregivers/parents
- Type 1 diabetes according to the ADA classification within the previous 3 months at the time of screening
- Age 4.00 -9.99 years at Diagnosis of Type 1 diabetes
- Fasting C-peptide \>0.12 nmol/ml
- Elevated levels of any diabetes-related antibody/ies (eg GADA, IAA, IA-2A, ZnT8A ) is/are present.
You likely can't join if
- Cardiac disease/problems, abnormal ECG, or history of abnormal blood pressure
- Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
- Continuous treatment with any inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
- Treatment with any oral or injected anti-diabetic medications other than insulin
- A history of anaemia or significantly abnormal haematology results at screening
- Participation in other clinical trials with a new chemical entity within the previous 3 months
See the full eligibility criteria
- Informed consent given by patients and caregivers/parents
- Type 1 diabetes according to the ADA classification within the previous 3 months at the time of screening
- Age 4.00 -9.99 years at Diagnosis of Type 1 diabetes
- Fasting C-peptide \>0.12 nmol/ml
- Elevated levels of any diabetes-related antibody/ies (eg GADA, IAA, IA-2A, ZnT8A ) is/are present.
- Cardiac disease/problems, abnormal ECG, or history of abnormal blood pressure
- Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
- Continuous treatment with any inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
- Treatment with any oral or injected anti-diabetic medications other than insulin
- A history of anaemia or significantly abnormal haematology results at screening
- Participation in other clinical trials with a new chemical entity within the previous 3 months
- Inability or unwillingness to comply with the provisions of this protocol
- A significant illness other than diabetes within 2 weeks prior to first dosing. However treated celiac disease and hypothyroidism with adequate treatment will be accepted.
- Deemed by the investigator not being able to follow instructions and/or follow the study protocol
The study team makes the final eligibility decision.
Where it's taking place
- Jönköping, Sweden
- Linköping, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 9 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jönköping, Sweden; Linköping, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.