Clinical trial in humans reveals that verapamil is an effective therapy for type 1 diabetes



  clinical trials Anath Shalev CREDIT: UAB

Researchers at the University of Alabama at Birmingham Comprehensive Diabetes Center have discovered a new safe and effective therapy to reduce insulin requirements and episodes of hypoglycemia in adult subjects with type 1 diabetes of recent onset promoting the function of beta cells and the patient's insulin production, the first discovery of this type aimed at diabetes in this way.

The findings, published this week by Nature Medicine reveal that oral administration of verapamil, a common medication for blood pressure first approved for medical use in 1981, allowed patients to produce more levels. high in your own insulin, limiting your need for insulin injections to balance your blood sugar levels.

The randomized, double-blind, placebo-controlled trial in humans identified verapamil as a safe, effective and promising therapy, an innovative finding in the field of the day betes research.

"The data collected from our clinical trial gives us all the indications to believe that people with type 1 diabetes have the promise of a treatment approach that would reduce their external insulin requirements and improve their control of blood sugar and their quality of life, thanks to the effects of verapamil in promoting the function of the body's own beta cells, "said Dr. Anath Shalev, director of the UAB Comprehensive Diabetes Center and principal investigator of the trial. "While this research is not a final cure for type 1 diabetes, these findings bring us closer to therapies that alter the disease and that allow people with type 1 diabetes to have more control over their disease and keep some of the insulin in the body. own body production. "

In 2014, Shalev's UAB research lab discovered that verapamil completely reversed type 1 diabetes in animal models and sought to test the effects of the drug on human subjects in a clinical trial, funded by a grant of $ 2.1 million from the JDRF. Verapamil has been approved by the Food and Drug Administration and is available for prescription for the treatment of high blood pressure for more than three decades. However, Shalev's research marks the first time the safety and efficacy of the drug in the treatment of type 1 diabetes has been proven.

Type 1 diabetes occurs as a result of the immune system attacking the beta cells of the pancreas that produce insulin to regulate and maintain optimal blood sugar levels. When beta cells are destroyed, a person's ability to produce insulin decreases, which causes blood sugar levels to rise and the person to become increasingly dependent on external insulin. The UAB clinical trial found that when a patient takes verapamil, the beta cell function is preserved, allowing the body to produce more of its own insulin. This decreased dependence of clinical trial participants on external insulin, which all people with type 1 diabetes must have to effectively regulate their blood sugar levels.

"At JDRF, we are excited and encouraged by the recent findings of the UAB Comprehensive Diabetes Center's clinical trial.This data has the potential to change the way we think about treatment and, ultimately, cure T1D "explains Andrew Rakeman, PhD, assistant vice president of research at JDRF. "We hope to continue the clinical studies that will build and confirm these findings, expanding to additional patient populations and guiding how, when and on whom verapamil could have the greatest impact on T1D."

The clinical trial of verapamil monitored 24 patients aged 18 to 45 years, each in the course of one year. Eleven patients received verapamil and 13 received placebo. All participants in the clinical trials were diagnosed with type 1 diabetes within three months of their start in the trial and continued with the insulin pump therapy prescribed throughout the study. The researchers controlled the total daily insulin dose of the placebo and the verapamil group, the amount of insulin produced, the percentage change in insulin production, and their HbA1C levels. In addition, the number of episodes of hypoglycaemia experienced by the patients was recorded and the percentage of time each patient recorded in healthy blood glucose ranges was analyzed using a continuous glucose monitoring system.

"Although this is a smaller sample group, our trial results promise us that subjects with type 1 diabetes have therapeutic options and that we are close to a more effective way to treat this disease," said Fernando Ovalle , MD, director of the comprehensive diabetes clinic of the UAB and co-principal investigator of the study. "Beyond verapamil, which allows subjects with type 1 diabetes the ability to live a life with less external insulin dependence, these findings will affect the quality of life they may have, fortunately, by improving overall control of blood sugar It will also limit your risks for other comorbidities, including heart attack, blindness, kidney disease, and more. "

While this study specifically addresses the findings in adult subjects diagnosed within three months of the start of the trial, Shalev points out that long-term studies are needed to help determine the effect of verapamil in both the pediatric population with type diabetes 1 as in people with type 1 diabetes who have lived or have been diagnosed with the disease for more than three months. In addition, the effects of verapamil in type 2 diabetes have not been tested or studied in prospective controlled trials; Shalev said future studies are also needed to explore the potential of this regimen to positively impact type 2 diabetes. However, in mouse models of type 2 diabetes and in recent epidemiological studies, the use of verapamil has been associated with a lower risk of developing type 2 diabetes and better control of blood sugar.

"The results of this test affirm that we are on the right track and are entering a new phase of discovery when it comes to this disease," Shalev said. "Diabetes affects more than 30 million people in the United States alone, and hopefully our progress will eventually lead to approaches that can help improve the lives of everyone affected by this disease."

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