Equivalence on Efficacy and Safety of Two Formulations of Insulin Glargine (Biosimilar and Reference) in the Treatment of Patients with Type 2 Diabetes Mellitus
Clinical Medicine Research
Volume 3, Issue 2, March 2014, Pages: 50-55
Received: Mar. 14, 2014; Accepted: Apr. 9, 2014; Published: Apr. 20, 2014
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Authors
Hernandez-Bastida, Antonio, Nuevo Hospital Obregon, Mexico City, Mexico
Meixueiro-Montes de Oca, Raúl, Laboratorios PiSA, Mexico City, Mexico
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Abstract
Use of biosimilars has allowed the access to biopharmaceuticals to a more patients in the World. Insulin galrgine is an analogue of human insulin to provide consistent level of plasma insulin over a long duration. The aim of this study was compare the safety and efficacy of insulin glargine biosimilar vs reference in individuals with type 2 diabetes. One hundred two type 2 diabetic individuals (64 female and 38 male) were studied in a single center, randomized, comparative study. The patients received during 12 weeks insulin glargine biocomparable or reference at doses of 0.4 to 0.7 IU/kg/day by subcutaneous via. Glycosylated hemoglobin (Hb1Ac), Fasting blood glucose (FBG), and lipid profile were evaluated during the study. Health-related quality of life was evaluated using the 36-item Short Form questionnaire. Hb1Ac, FBG and lipid profile improved significantly from to start to endpoint in both groups. No significant differences were found between both groups. A total of 80.8 and 77.2% of patients had HbA1c < 7.5% and 66,6% and 69.5% achieved the FBG target, for reference and biosimilar insulin glargine, respectively. No significant reductions in body weight were observed between the start and the end of the study. The adverse event more reported was hypoglycemia. There was no apparent association between the levels of cross-reacting antibodies and Hb1Ac, body weight, insulin dose, or hypoglycemic episodes Improvements in both mental and physical health status were found, but no differences significant were found between the groups. We conclude that insulin galrgine biocomparable was similar since the safety and efficacy point of view with insulin glargine of reference in patients with diabetes mellitus 2
Keywords
Type 2 Diabetes Mellitus, Biosimilar, Insulin Glargine, Efficacy, Safety
To cite this article
Hernandez-Bastida, Antonio, Meixueiro-Montes de Oca, Raúl, Equivalence on Efficacy and Safety of Two Formulations of Insulin Glargine (Biosimilar and Reference) in the Treatment of Patients with Type 2 Diabetes Mellitus, Clinical Medicine Research. Vol. 3, No. 2, 2014, pp. 50-55. doi: 10.11648/j.cmr.20140302.19
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