1113-P: Six Months Comparative Evaluation of Efficacy and Safety of Wockhardt’s Biosimilar Insulin Glargine (Glaritus®) with Reference Insulin Glargine (Lantus®) in Type 2 Diabetes Mellitus in India

Abstract

Introduction: Glaritus® has been found comparable to reference insulin glargine in physico-chemical characteristics, pre-clinical studies and treatment of type 1 diabetes mellitus (DM). Objective: To compare the immunogenicity, HbA1c reduction and safety of Glaritus® to Lantus® over 6 months treatment in type 2 DM. Methods: This is an ongoing prospective, open-label, randomized, multicentre Phase IV study. Total 180 patients of type 2 DM, who were inadequately controlled on oral antidiabetic drugs, were randomized in 1:1 ratio to Glaritus® and reference insulin glargine treatment. Analysis of 144 patients, who completed 6 month comparative phase, is presented herewith. Results: Baseline characteristics of both the treatment arms were comparable in terms of age, gender distribution and body mass index. Over the treatment period, mean anti-insulin antibody titre increased marginally, mean HbA1c reduced significantly and substantial percentage of patients attained HbA1c value <7% within each treatment arm. However, both arms were comparable (P>0.05) in terms of these changes. Both glargine treatments were found to be safe in terms of hypoglycemic events. Conclusion: Glaritus® was found to be equally effective and safe in patients with inadequately controlled T2DM compared to reference insulin glargine. Disclosure S. Sharma: None. A. Ajmani: None. P. Khosla: None. P. Mukhopadhayay: None. G. Bhatia: None. P. Kg: None. G. Chhaya: None. P. Supe: None. V. Pavithran: None. H. Bora: None. A. Shah: Employee; Self; Wockhardt. S.A. Ingole: Employee; Self; Wockhardt. R. Jain: Employee; Self; Wockhardt. Funding Wockhardt Pharmaceuticals Ltd.