Safety and Effectiveness of insulin Humalog Mix 25(R) in Patients with Type 1 and Type 2 Diabetes Mellitus

Won, Jong Chul; Park, Cheol Young; Oh, Ki Won; Kim, Hung Dai; Jo, Min Ho; Ryu, Jae Myung; Kang, Jun Kyu; Ihm, Sung Hee; Yoo, Hyung Joon; Park, Sung Woo

Original Article

Clinical Diabetes 2007;8(3):261-269.

당뇨병환자에서 Humalog Mix 25펜주(R)의 안전성 및 유효성에 대한 연구

원종철, 박철영, 오기원, 김흥대, 조민호, 유재명, 강준구, 임성희, 유형준, 박성우

Safety and Effectiveness of insulin Humalog Mix 25(R) in Patients with Type 1 and Type 2 Diabetes Mellitus

Jong Chul Won, Cheol Young Park, Ki Won Oh, Hung Dai Kim, Min Ho Jo, Jae Myung Ryu, Jun Kyu Kang, Sung Hee Ihm, Hyung Joon Yoo, Sung Woo Park

Abstract

Background
Humalog Mix 25(R), a premixed insulin mixture of 25% insulin lispro and 75% insulin lispro protamine suspension, serves to more convenient and practical advantages of addressing both prandial and basal insulin needs with a single product. The primary objectives of this study were to assess the effectiveness and safety of Humalog Mix 25(R) in the treatment of patients with type l and type 2 diabetes mellitus with uncontrolled hyperglycemia. Methods: This study was an open-label, non-comparative, multicenter, observational design, with an optional 24-month extension phase, in which starting the therapy with Humalog Mix 25(R) was initiated in 1,117 patients with type 1 and type 2 diabetes with inadequate control. The dose was adjusted at the physician`s discretion, reflecting everyday practice. The main outcome measures were safety profiles and changes in HbA1c (AIC), fasting plasma glucose (FPG), and postprandial plasma glucose (PPG). Results: There were neither clinically significant hypoglycemic episodes nor any adverse effects directly associated with Humalog Mix 25(R) during the observation period. Only, there were 7 mild hypoglycemic episodes and transient hepatic coma associated with underlying liver disease. At the end of observation period, treatment with Humalog Mix 25(R) resulted in significant decrease in AIC (9.5 ± 2.5% vs. 8.2 ± 1.7%, P < 0.001), FPG (11.61 ± 4.75 mmol/mL vs. 8.19 ± 2.62 mmol/mL, P < 0.001), and PPG (17.16 ± 5.66 mmol/mL vs. 11.16 ± 4.38 mmol/mL, P < 0.001). Conclusion: when glycemic control is poor in patients with type l and type2 diabetes, treatment with insulin should be considered as the next therapeutic option. Humalog Mix 25(R) provided safe and good overall glycemic control, as well as convenience.

Key Words: Diabetes, Humalog mix 25, insulin Llispro