Type 1 diabetes (T1D) is an autoimmune disease in which the body’s immune system destroys the cells in the pancreas that produce insulin. The disease most commonly starts in childhood but can develop in adults as well. As a result of damage to the pancreas, high blood sugars (hyperglycemia) occur and daily insulin treatment is needed.
Results of the CLVer clinical trial reported today at the International Conference on Advanced Technologies and Treatments of Diabetes (ATTD) and published online in JAMA showed that oral verapamil taken once a day improved the pancreas’ insulin secretion by 30% over the first year following diagnosis of T1D when compared with a control group that received a placebo. The trial included 88 children 8 to 17 years old who started the trial within 31 days of their T1D diagnosis. Participants were randomly assigned to receive either oral verapamil or a matching placebo. The dose of the drug was based on the weight of the participant. Participants had to weigh at least 66 lbs to be in the trial due to the lowest dose of the drug that was available.
Participants were monitored for known side effects of verapamil, including effects on the heart, blood pressure, and liver function. The study found that verapamil was well tolerated and very few of these side effects occurred.
“The fact that verapamil is inexpensive, already on the market, and easily administered with a very low side effect profile makes this a very exciting therapy for children with newly diagnosed type 1 diabetes. We are very excited to be able to add this to the options available to improve the lives of children with type 1 diabetes,” said Gregory Forlenza, MD, associate professor and protocol co-chair at the University of Colorado Anschutz Medical Campus.
In addition to evaluating verapamil, the trial also assessed whether an intensive glucose management approach that included use of an automated insulin delivery system to try to get glucose levels as close to normal as possible could have a beneficial effect on the pancreas’ insulin secretion. As reported in a companion paper in JAMA, much better glucose levels were achieved with this approach compared with standard care that included use of continuous glucose monitoring; however, unfortunately a benefit on the pancreas was not observed. Nevertheless, the excellent glucose levels achieved could have long-term benefit in reducing complications of diabetes.
“Safe, effective therapies are urgently needed to delay disease progression in people recently diagnosed with T1D, an area of high priority for JDRF (formerly the Juvenile Diabetes Research Foundation),” said Sanjoy Dutta, PhD, chief scientific officer at JDRF which provided the funding for the study. “This is the second trial showing that verapamil, a cheap and widely used blood pressure medication, can preserve beta cells in the new onset period. The CLVer trial moves us one step closer to our goal of having disease modifying therapies widely available for people with T1D.”
The Barbara Davis Center for Diabetes at the University of Colorado School of Medicine was one of six pediatric diabetes centers in the U.S. that participated in the study. In addition to the funding provided by JDRF, Dexcom, Medtronic, and Tandem Diabetes Care provided devices and supplies used in the study.