ABSTRACT
BACKGROUND: Insulin glulisine is a new rapid-acting insulin analogue. Currently, few data are available on its safety and tolerability among patients in the Asia-Pacific region.OBJECTIVES:Primary Objective: To assess the safety and tolerability of insulin glulisine as part of an insulin treatment regimen in Filipinos with diabetesSecondary Objectives:1. To compare the change in glycosylated hemoglobin (HbA1c), fasting blood glucose (FBG) and post-prandial blood glucose (PPBG) levels at baseline and after three and six months on an insulin treatment regimen with insulin glulisine2. To measure patients' level of satisfaction in using the Insulin glulisine penMETHODS: This was a multicenter, observational, post- marketing surveillance study of adult patients (18 to Results: Among 1,805 patients included, 132 (7.31%) experienced hypoglycemia. The overall incidence of adverse events other than hypoglycemia was 0.78%. There was a significant reduction in baseline levels of HbA1c, FBG and PPBG during the follow-up visits at third and sixth months (all pCONCLUSION: This post-marketing surveillance study demonstrates the safety and tolerability of insulin glulisine when used as part of an insulin regimen in an actual clinical setting for the management of diabetes among Filipino patients. Insulin glulisine as part of a diabetes treatment regimen was effective in improving glycemic parameters. The glulisine pen was also well tolerated and accepted by patients.