Amylin Pharmaceuticals Inc and Eli Lilly and Company has completed enrollment for the first of three ongoing Phase 3 pivotal trials of AC2993 (synthetic exendin-4) for the treatment of type 2 diabetes. This study will evaluate the ability of AC2993 to improve glucose control in people with type 2 diabetes who are currently not achieving target blood glucose levels with metformin. The companies remain on track to announce results from this study in the first half of 2003.
In September 2002, Amylin and Lilly announced a global agreement to collaborate on the development and commercialization of AC2993.
Study participants are being randomized into three groups: two on AC2993 and one on placebo. Those on active drug are to receive an introductory 5 microgram dose of AC2993 for one month, given by subcutaneous injection twice a day at breakfast and dinner. This is followed by six-months of exposure to doses of either 5 micrograms or 10 micrograms given twice a day at breakfast and dinner. Participants who complete the study will be given the opportunity to enter an open-label extension.
This study is one of three pivotal Phase 3 studies in the "AC2993: Diabetes Management for Improving Glucose Outcomes" (AMIGO) development program. The AMIGO studies are aimed at evaluating AC2993's ability to improve glucose control in people with type 2 diabetes who are currently not achieving target blood glucose levels with metformin and/or sulfonylureas. The second study, initiated in January 2002, will evaluate the effects of AC2993 when added to sulfonylureas alone. The third study, initiated in April 2002, will evaluate the effects of AC2993 when added to the combination of metformin and sulfonylureas.
"The completion of enrollment for this trial is an important step for AC2993, and brings Amylin and Lilly closer to providing another potential treatment option for people with diabetes," said Alain D. Baron, Amylin's Senior Vice President of Clinical Research. "We are pleased with the progress of our recruitment efforts in the AMIGO program and remain on track to complete enrollment in the remaining two pivotal trials before the end of the year."
AC2993 (synthetic exendin-4) is being studied for its potential to address important unmet medical needs of people with type 2 diabetes. Clinical trials suggest that AC2993 decreases blood glucose toward normal levels. This control of blood glucose is likely due to exendin-4 actions that are similar to those of GLP-1. These actions include glucose-dependent stimulation of insulin secretion, suppression of glucagon secretion, reduction of appetite and slowing of gastric emptying.