Top-Line Data Expected in Third Quarter 2013
DANBURY, CN, USA I March 28, 2013 I Biodel Inc. (BIOD) today announced the completion of patient enrollment in a Phase 2 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(R) on measures of HbA1c, postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes.
Dr. Errol De Souza, president and chief executive officer of Biodel, stated: "Completing enrollment of the BIOD-123 Phase 2 clinical trial is a significant milestone for Biodel, having nearly doubled the number of subjects in our original trial design without changing the timelines. This larger Phase 2 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 2 trial of BIOD-123 is a randomized, open label, parallel group study being conducted at approximately 30 investigative centers in the United States. In the trial, approximately 130 patients with type 1 diabetes were randomized to receive either BIOD-123 or Humalog(R) to use as their mealtime insulin during an 18 week treatment period. Both arms of the study use insulin glargine, sold as Lantus(R), 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.
About Biodel Inc.
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. We develop our product candidates by applying our proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles.
SOURCE: Biodel
Post Views: 139
Top-Line Data Expected in Third Quarter 2013
DANBURY, CN, USA I March 28, 2013 I Biodel Inc. (BIOD) today announced the completion of patient enrollment in a Phase 2 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(R) on measures of HbA1c, postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes.
Dr. Errol De Souza, president and chief executive officer of Biodel, stated: "Completing enrollment of the BIOD-123 Phase 2 clinical trial is a significant milestone for Biodel, having nearly doubled the number of subjects in our original trial design without changing the timelines. This larger Phase 2 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 2 trial of BIOD-123 is a randomized, open label, parallel group study being conducted at approximately 30 investigative centers in the United States. In the trial, approximately 130 patients with type 1 diabetes were randomized to receive either BIOD-123 or Humalog(R) to use as their mealtime insulin during an 18 week treatment period. Both arms of the study use insulin glargine, sold as Lantus(R), 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.
About Biodel Inc.
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. We develop our product candidates by applying our proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles.
SOURCE: Biodel
Post Views: 139
