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

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 treatme...

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Bibliographic Details
Published in:	Diabetes (New York, N.Y.) Vol. 68; no. Supplement_1
Main Authors:	SHARMA, SURENDRA, AJMANI, AJAY KUMAR, KHOSLA, POOJA, MUKHOPADHAYAY, PRADIP, BHATIA, GIRISH, KG, PRAKASH, CHHAYA, GAURAV, SUPE, PRAVIN, PAVITHRAN, VINODKUMAR, BORA, HRISHIKESH, SHAH, AGAM, INGOLE, SHAHU ASHOK, JAIN, RISHI
Format:	Journal Article
Language:	English
Published:	New York American Diabetes Association 01-06-2019
Subjects:	Age composition Body mass index Diabetes Diabetes mellitus Diabetes mellitus (insulin dependent) Diabetes mellitus (non-insulin dependent) Immunogenicity Insulin Patients
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Summary:	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.
ISSN:	0012-1797 1939-327X
DOI:	10.2337/db19-1113-P