A PROSPECTIVE, OPEN-LABEL, RANDOMIZED, CONTROLLED, MULTICENTRE, CLINICAL TRIAL TO EVALUATE THE IMMUNOGENICITY, SAFETY AND EFFICACY OF WOCKHARDTS BIOSIMILAR INSULIN GLARGINE (GLARITUS) WITH REFERENCE INSULIN GLARGINE (LANTUS) IN TYPE 2 DIABETES MELLITUS

doi:10.4066/biomedicalresearch-C5-013

A PROSPECTIVE, OPEN-LABEL, RANDOMIZED, CONTROLLED, MULTICENTRE, CLINICAL TRIAL TO EVALUATE THE IMMUNOGENICITY, SAFETY AND EFFICACY OF WOCKHARDTS BIOSIMILAR INSULIN GLARGINE (GLARITUS) WITH REFERENCE INSULIN GLARGINE (LANTUS) IN TYPE 2 DIABETES MELLITUS

Joint Event on 2^nd WORLD OBESITY CONGRESS & International Conference on DIABETES AND ENDOCRINOLOGY & 2^nd WORLD VACCINES AND IMMUNOLOGY CONGRESS
October 15-16 , 2018 | Tokyo , Japan

Agam Shah, Jain R, Ajmani AK, Sharma SK, Mukhopadhyay P, Chhaya G, Supe PD, Pavithran V and Bora H

Wockhardt Ltd., India BL Kapoor Hospital, India Diabetes, Thyroid and Endocrine Centre, India Institute of Post Graduate Medical Education and Research, India Sanjivani Superspeciality Hospital, India Supe Heart & Diabetes Hospital and Research Centre, India KVM Hospital, India Down Town Hospital, India

Scientific Tracks Abstracts : Biomed Res

DOI: 10.4066/biomedicalresearch-C5-013

Abstract:

Introduction: Insulin glargine provides a peak-less glucose lowering profile and a prolonged duration of action that permits once daily dosing. Biosimilar insulin analogues are compared on immunogenicity, safety and efficacy to the reference biological product. Objective: Primary objective is to evaluate percent change in anti-insulin antibody [AIA] to glargine in Glaritus® or Lantus® treatment arms from baseline to six months. Secondary objective is to evaluate the change in HbA1c and safety in both arms at six months as well as immunogenic response and safety in Glaritus® arm at 12 months. Methods: This is a prospective, open-label, randomized, controlled, multicentre study in 180 type 2 diabetes mellitus (T2DM) patients inadequately controlled on oral hypoglycaemic agents. Eligible patients were randomized to either Glaritus® for 12 months or Lantus® for six months. Treatment was started at 10 units once daily, which was subsequently adjusted according to the subject’s glycaemic control. This is an interim analysis of the six months data from the ongoing study. Results: Out of 90 patients each randomized to Glaritus® and Lantus® arms across 10 sites, 76 (84.4%) and 68 (75.6%) patients completed six months treatment, respectively. There was no significant difference in percent change in AIA titre between the groups at six months (least square [LS] mean difference [95% CI]: 3.4% [-15.1%, 21.9%], p=0.7181). In terms of reduction in HbA1c at six months, the difference between two arms was not significant (LS mean diff [95% CI]: -0.1 [-0.3, 0.1], p=0.2283) and the upper margin of 95% CI was <0.4% (non-inferiority margin). Overall incidence of adverse events was comparable between the groups with intensity being mild (36/37) and outcome resolved (32/37) for most patients. Conclusion: Glaritus® was found to be non-inferior to Lantus® in glycaemic control and comparable in immunogenic response and safety in T2DM treatment over six months.

Biography:

Agam Shah has rich professional experience of nearly 15 years in clinical development, medical affairs and academics. He has been an avid Clinical Research Physician with numerous scientific publication and presentations to his name. He has comprehensive experience of clinical development of biosimilars, complex generics and vaccine products.

E-mail: ashah@wockhardt.com

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