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 diabetes

Secondary 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 glulisine

2. To measure patients’ level of satisfaction in using the Insulin glulisine pen

Methods: This was a multicenter, observational, post-marketing surveillance study of adult patients (18 to <75 years old) with type 1 or type 2 diabetes mellitus who were prescribed with insulin glulisine as part of their diabetes treatment regimen, and signed a data release consent form. Patients who were pregnant and had known allergy to insulin glulisine and any of its excipients were excluded. Patients were followed up for treatment duration of six months inclusive of a baseline visit and two follow up evaluations falling at third month and sixth months of treatment. The incidence of hypoglycemia and other adverse events was determined. Changes in baseline levels of HbA1c, FBG and PPBG were measured during follow-up visits at third and sixth months. Patient satisfaction with the Insulin glulisine pen was quantified using a five-point scale questionnaire.

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 p<0.0001). Patient satisfaction with using the pen was good to excellent.

Conclusion: 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.

Trial Registration Number: APIDR_L_03772

Keywords: insulin glulisine, diabetes mellitus, safety, hypoglycemia

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