Biodel Completes Phase II Enrollment in Clinical Trial of Ultra-Rapid-Acting Insulin
Biodel Inc. recently announced the completion of patient enrollment in a Phase II clinical study of ultra-rapid-acting prandial insulin candidate BIOD-123 for the treatment of diabetes. The trial will evaluate the use of BIOD-123 versus Humalog on measures of HbA1c, postprandial glucose excursions, glycemic variability, hypoglycemic event rates, and weight changes.
“Completing enrollment of the BIOD-123 Phase II clinical trial is a significant milestone for Biodel, having nearly doubled the number of subjects in our original trial design without changing the timelines,” said Dr. Errol De Souza, President and CEO of Biodel. “This larger Phase II trial will allow us to more effectively test the benefits of a product candidate that has a more rapid absorption profile than currently marketed insulins. We remain on track to report top line data from this trial in the third calendar quarter of 2013.”
The Phase II trial of BIOD-123 is a randomized, open label, parallel group study being conducted at approximately 30 investigative centers in the US. In the trial, approximately 130 patients with type 1 diabetes were randomized to receive either BIOD-123 or
Humalog to use as their mealtime insulin during an 18-week treatment period. Both arms of the study use insulin glargine, sold as Lantus, as the basal insulin. The clinical trial will evaluate HbA1c control as the primary endpoint, and secondary endpoints include postprandial glucose excursions, glycemic variability, hypoglycemic event rates, and weight changes.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective, and more convenient for patients. The company develops its product candidates by applying proprietary formulation technologies to existing drugs to improve their therapeutic profiles. For more information, visit www.biodel.com.
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