VolumeVol. 53 • Number No. 3 • July - September 2015 Back

Clinical Trials

​​​​​​​Safety and Effectiveness of Insulin Lispro Mix 25/75 Among Filipino Patients with Type 1 or Type 2 Diabetes Mellitus: A Post-Marketing Surveillance Study

Authors: Mary Ann Roa, Cecille Cruz, Yun Chen,  Steve C Chen, Diana M Edralin

DOI: 10.65564/pjim.4fed08f307

Date of Publication: September 2015

Abstract

Background: Diabetes mellitus (DM) is a major cause of morbidity and mortality in the Philippines. Improvement in hemoglobin A1c (HbA1c) remains below recommended targets for Filipino patients. Safe and effective therapies are needed for this population.

Objective: To investigate treatment-emergent adverse events (TEAEs) and change in HbA1c among Filipino patients with DM treated with insulin lispro mix 25/75 in a real-world setting.

Materials and Methods: This was a prospective, non-interventional, post-marketing surveillance study among 459 Filipinos aged 18 years or older with type 1 or 2 DM. Patients were treated with insulin lispro mix 25/75 according to the approved label, as prescribed by the investigators, and observed for 12 weeks. Occurrence of all TEAEs and change in HbA1c from baseline to final visit were reported.

Results: Mean (SD) treatment duration was 12.93 (5.7) weeks, and mean total daily dose was 0.62 (0.29) units/kg. Eighteen patients (3.9%) experienced 23 TEAEs, the majority of which were mild. None were reported to be related to treatment. No serious TEAEs or hypoglycemic episodes were reported. Mean (95% confidence interval) HbA1c was significantly reduced by -2.03% (-2.19%, -1.87%), and 36.3% of patients achieved HbA1c <7.0% at 12 weeks.

Conclusion: In this observational study, no treatment-related safety signals using insulin lispro mix 25/75 were detected among Filipino diabetic patients. HbA1c was significantly reduced in Filipino patients with DM at 12 weeks.

Keywords: diabetes mellitus, insulin lispro, Philippines, post-marketing product surveillance

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