Clinical Results Of VLD-Glucagon For Nocturnal Hypoglycemia Are Promising
DIO-901, a Very Low Dose Glucagon (VLD(TM)-Glucagon), can delay or prevent nocturnal hypoglycemia and reduce the number and duration of hypoglycemic episodes.
DIO-901 is under evaluation as a potential treatment to reduce or prevent hypoglycemia (low blood sugar) in type 1 diabetes.
The oral presentation entitled, "Nocturnal Administration of Very Low Dose Glucagon in Patients with Type 1 Diabetes Reduces Episodes of Nocturnal Hypoglycemia," was presented today at the 67th Annual Scientific Sessions of the American Diabetes Association (ADA) in Chicago, IL by Steven V. Edelman, M.D., Professor of Medicine, University of California, San Diego, School of Medicine, and host of the television talk show series, Taking Care of Your Diabetes. The study enrolled patients with type 1 diabetes mellitus and was designed to assess safety and tolerability and to provide early signs of the effect of DIO-901 on the incidence of hypoglycemia and other pharmacodynamic measures.
"Fear of hypoglycemia is a major factor limiting insulin intensification," said Dr. Edelman. "While intensive insulin therapy is the gold standard in achieving the best levels of glycemic control, this treatment option also leads to a substantially higher risk of severe hypoglycemic episodes, over half of which occur at night. DIO-901 may be able to help patients combat nocturnal hypoglycemia and reduce the frequency of the severe and life- threatening events associated with insulin intensification. With a treatment option such as DIO-901, type 1 diabetes patients and their physicians would be presented with a therapeutic that could facilitate the more widespread use of insulin intensive therapies to improve glycemic control, which reduces the long-term complications of diabetes such as nerve damage, kidney failure and retinopathy."
The trial of DIO-901 consisted of 6 subjects with type 1 diabetes mellitus, each studied for 10 overnight stays. Patients received their usual insulin regimens and were treated with nocturnal subcutaneous infusions of a control infusion for one night as well as DIO-901 at 3different dose levels, each for 3 varying durations. Glucose control was measured by use of a continuous glucose monitor which measures glucose levels every 5 minutes, as well as by frequent blood tests. Use of the continuous glucose monitor enabled the assessment of the incidence of hypoglycemic events as well as their duration.
DIO-901 is the only product in development for prevention or reduction of nocturnal hypoglycemia. It is estimated that at least 50 percent of type 1 diabetes patients suffer from nocturnal hypoglycemia. In 2005, the FDA recognized the severe unmet medical need addressed by DIO-901, and granted DiObex Fast-Track status for the program.
"This study of DIO-901 was particularly important and we are very pleased with the results," said David A. Cory, Chief Executive Officer of DiObex, Inc. "The trial was designed to determine the optimal dose and pharmacokinetics necessary to inform the development of a patient-friendly, subcutaneous injection of extended-release formulation of DIO-901. We have invested significant resources into the DIO-901 program and look forward to the further advancement of the program with our new formulation. We intend to begin clinical trials with our extended-release product in 2008."