Adding metreleptin to insulin therapy improves blood glucose control and helps regulate blood lipid (including cholesterol) levels, according to a new study conducted on rodents. Metreleptin is closely related to the human hormone leptin, which plays a fundamental role in the regulation of fat and glucose metabolism in the body.
A new clinical trial, funded by JDRF and Amylin Pharmaceuticals, Inc., is underway at the University of Texas (UT) Southwestern Medical Center to help determine if people with type 1 diabetes will experience a similar improvement from the combination of insulin and metreleptin.
In this proof-of-concept clinical study, 12 to 15 participants will take metreleptin twice a day in conjunction with their insulin therapy. The amount of insulin will be gradually reduced over a period of five months in order to observe the effect of metreleptin on blood glucose levels in people with type 1 diabetes.
“If it works in humans as well as it does in rodents, it will be a major step forward,” says Roger Unger, M.D., professor of internal medicine at UT Southwestern. “In rodents, it eliminated the wide swings in glucose that occur with insulin alone and lowered the indices of cholesterol formation. The hope is that it will improve both the short- and long-term quality of life for patients with type 1 diabetes.”
The financial support that JDRF and Amylin agreed to provide to UT Southwestern is part of JDRF’s Industry Discovery and Development Partnerships (IDDP) program. The IDDP initiative seeks to partner with pharmaceutical, biotechnology, and medical device companies focused on the discovery, development, and delivery of therapeutics for type 1 diabetes and its complications. Since the IDDP program was established in 2004, JDRF has funded 35 partnerships with 32 companies and committed approximately $72 million to accelerate research that will lead to better treatments and a cure for type 1 diabetes.
“If effective in humans, metreleptin, when used with insulin, could change the way people manage their disease,” says Aaron Kowalski, Ph.D., assistant vice president of treatment therapies at JDRF.