Equivalence on efficacy and safety of two formulations of insulin glargine (biosimilar and reference) in the treatment of patients with type 2 diabetes mellitus
2014
Use of biosimilars has allowed the access to biopha rmaceuticals to a more patients in the World. Insul in galrgine is an analogue of human insulin to provide consiste nt level of plasma insulin over a long duration. Th e 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 m ale) were studied in a single center, randomized, c omparative study. The patients received during 12 weeks insulin glargine biocomparable or reference at doses of 0.4 to 0.7 I U/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 evalu ated using the 36-item Short Form questionnaire. Hb 1Ac, FBG and lipid profile improved significantly from to start to end point in both groups. No significant differences we re found between both groups. A total of 80.8 and 77.2% of patients had H bA1c < 7.5% and 66,6% and 69.5% achieved the FBG target, for reference and biosimilar insulin glargine, respectively. No s ignificant reductions in body weight were observed between the start and the end of the study. The adverse event more report ed was hypoglycemia. There was no apparent association between the levels of cross-reacting antibodies and Hb1Ac, body weight, insulin dose, or hypoglycemic episodes Imp rovements in both mental and physical health status were found, but n o differences significant were found between the gr oups. We conclude that insulin galrgine biocomparable was similar since th e safety and efficacy point of view with insulin gl argine of reference in patients with diabetes mellitus 2.
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