In short
Clinical trials are studying Verapamil Hydrochloride in adults with newly diagnosed type 1 diabetes and in adults already followed in a long-term extension study. These trials are looking at beta-cell function, which means how well the insulin-making cells in the pancreas are working, and whether treatment helps preserve that function over time.
Key points
- Clinical trials of Verapamil Hydrochloride are focusing on adults with type 1 diabetes mellitus. One completed Phase 2 study tested whether treatment could help preserve beta-cell function compared with placebo over 12 months. A second Phase 2 open-label extension study is looking at longer-term treatment over 24 months in adults who were already in the earlier trial. The main outcome in both studies is C-peptide measured during a mixed meal tolerance test, which shows how much insulin the body is still making. Together, these trials are exploring whether Verapamil Hydrochloride may help protect insulin-making cells in type 1 diabetes.
Trial overview
Two interventional studies are investigating Verapamil Hydrochloride in adults with type 1 diabetes mellitus. Both studies focus on whether treatment can help preserve beta-cell function, which means the work of the pancreas cells that make insulin.
The first study is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre Phase 2 trial in adults with newly diagnosed type 1 diabetes mellitus. The second study is an open-label extension, multi-centre Phase 2 trial in adults with type 1 diabetes who are continuing long-term follow-up.
Who is being studied
The main trial enrolled adult subjects with newly diagnosed type 1 diabetes mellitus. This means the study looked at people soon after diagnosis, when some insulin-making function may still be present.
The extension trial includes adult subjects diagnosed with type 1 diabetes mellitus and specifically notes follow-up in people who previously had a fasting C-peptide of at least 50 pmol/L and had earlier received placebo or Verapamil Hydrochloride in the first study. This shows the extension is focused on a selected group with measurable remaining insulin production.
Study designs and phases
The first study used a randomised design, which means participants were assigned by chance to a treatment group. It was also double-blind and placebo controlled, so neither the participants nor the study team knew who received active treatment or placebo during the trial.
The first study compared placebo with Verapamil Hydrochloride 360 mg given orally once daily for 12 months. The extension study is open-label, which means the treatment is known, and it follows participants for longer-term therapy over 24 months.
Both studies are Phase 2 trials. Phase 2 trials are early clinical studies that mainly look at whether a treatment may work in the target group and how outcomes change over time.
What is being measured
The main outcome in the first study is the area under the stimulated C-peptide response curve over the first two hours of a mixed meal tolerance test (MMTT) after 12 months of therapy compared with placebo. This outcome checks how much C-peptide the body makes after a meal-like test.
The extension study measures change over time in C-peptide area under the curve in adults receiving 360 mg oral Verapamil Hydrochloride daily during MMTT at baseline and after 24 months of therapy. In simple terms, the study is asking whether the body keeps making more of its own insulin over time.
C-peptide is a marker of natural insulin production, so it helps researchers understand how well the beta cells are still working.
Trial status and enrollment
The first trial, NCT04545151, is listed as completed and enrolled 120 participants. The second trial, 2024-515234-33-00, is listed as authorised and plans to enroll 40 participants.
These numbers show that the research is relatively small and focused on a specific patient group with type 1 diabetes.
Simple explanation of key terms
- Placebo means a treatment with no active study drug, used for comparison.
- Parallel-group means different groups are followed at the same time.
- Multi-centre means the trial takes place at more than one study site.
- Open-label extension means a follow-up study where treatment is known and the study continues for a longer time.
- Fasting C-peptide means the C-peptide level measured when a person has not eaten, which helps show remaining insulin production.