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NIH project aims to improve, preserve insulin production
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The NIH is currently seeking volunteers for one of three clinical trials in its Restoring Insulin Secretion study program to improve type 2 diabetes and prediabetes treatment. Two trials will include adults and the other will examine adolescents.
According to an NIH press release, Restoring Insulin Secretion (RISE) trial participants must have prediabetes or type 2 diabetes diagnosed within the past year.
One adult trial will compare gastric banding with standard advice and metformin for weight loss; 88 enrollees at the University of Southern California, Los Angeles, are planned. The second adult trial will compare placebo with metformin alone, metformin plus liraglutide (Victoza, Novo Nordisk) or insulin glargine (Lantus, Sanofi-Aventis); it aims to enroll 225 participants at the VA Puget Sound Health Care System, University of Washington, Indiana University and the University of Chicago.
“Along with comparing treatments in adults, the RISE studies will enable us to make direct comparisons between young people and adults with prediabetes and early type 2 diabetes in terms of how their bodies respond to treatments,” Griffin P. Rodgers, MD, director of the National Institute of Diabetes and Digestive and Kidney Diseases, said in the press release. “If successful, RISE studies will help to develop treatments that will slow the progression of prediabetes and diabetes.”
The third trial will compare metformin with glargine in participants aged 10 to 19 years and will be conducted at the Children’s Hospital Colorado, University of Colorado; Children’s Hospital of Pittsburgh; Yale University; and Indiana University. This study aims to enroll 90 adolescents.
Duration of all three studies is 5 years, and results will be compared head-to-head. Larger, definitive trials may be planned to study the most promising treatments.
“By examining the effects of different treatments in people with prediabetes and early type 2 diabetes, who still produce substantial amounts of insulin, we hope to learn how to reverse or slow the progressive loss of insulin production that comes with increasing duration of the disease, so that these people can stay healthier longer,” Peter Savage, MD, project scientist and senior adviser for clinical research at NIDDK, said in the release.