Hypoglycemia Data Analyses in Diabetes Studies

• Activity Number: 627
• Type: Contributed
• Date/Time: Thursday, August 5, 2010 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Yu Chen*+ and Yue Shentu and Bret Musser
• Companies: Merck & Co., Inc. and Merck & Co., Inc. and Merck Research Laboratories
• Keywords: Recurrence event ; incidence rate

Abstract

Hypoglycemia can occur as a complication of some diabetes medications. Diabetes medication candidate needs to demonstrate effectively controlled blood glucose level while avoiding excessive hypoglycemia episodes, which is considered a major adverse event. In order to differentiate the hypoglycemia risk profile of glucose-lowering agents for the treatment of diabetes, the crude/exposure-adjusted incidence rate, time to first incidence, and frequency of incidence are commonly analyzed, often based on the assumption of no correlation among the episodes within each patient. However, there's a sound clinical reason to believe patients with hypoglycemia are at increased risk of subsequent episodes. In this presentation, different data illustration methods and analysis metrics are compared using simulated hypoglycemia data taking into consideration of correlation among the episodes in a patient