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Immunogenicity, Safety and Efficacy Comparison of Wockhardt’s Biosimilar Insulin Glargine—Glaritus®with Reference Product— Lantus®: Study Protocol &Early Data Trends

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Open Journal of Endocrine and Metabolic Diseases 2018年第8期8卷 157-166页

作者： S. K. Sharma A. K. Ajmani P. Khosla P. Mukhopadhyay G. Bhatia K. G. Prakash G. Chhaya P. D. Supe V. Pavithran H. Bora R. Jain S. Ingole A. Shah Diabetes Thyroid and Endocrine Centre Jaipur India BL Kapoor hospital Delhi India Sir Ganga Ram hospital Delhi India Institute of Post Graduate Medical Education and Research Kolkata India Medipoint hospitals Pvt. Ltd. Pune India Bangalore Medical College and Research Institute Bangalore India Sanjivani Supers Peciality hospital Ahmedabad India Supe Heart and Diabetes hospital and Research Centre Nashik India kvm hospital Kerala India Downtown hospital Guwahati India Wockhardt Ltd. Mumbai India

Objective: Present Phase IV Trial is aimed at evaluating the immunogenicity, safety, and efficacy of Wockhardt’s insulin glargine, Glaritus®in comparison with reference insulin glargine, Lantus®in subjects with type 2 diabetes mellitus (T2DM), inadequately controlled on oral hypoglycaemics. Setting: A head-to-head, prospective, open-label, parallel group, randomized, Phase IV, non-inferiority study over 6 months treatment conducted in 10 centres in India. Participants: Considering 20% drop-out rate, 180 subjects of either sex, age 18 - 55 years, diagnosed with T2DM with body mass index (BMI) 18 - 38 kg/m2 and HbA1c levels 8.0% - 10.0% inadequately controlled by 1 or more oral hypoglycaemics and according to investigator needed glargine treatment were enrolled in the study. Interventions: Subjects self-administered insulin glargine (Glaritus®or Lantus®) subcutaneously once daily for 6 months. Treatment in Glaritus®arm was continued till 12 months. Percentage change in anti-insulin antibody (AIA) titre and HbA1C was ascertained at every 3 months interval. The tests were performed at accredited central laboratory. Treat-to-target dose titration: Starting doses of Glaritus®and Lantus®was 10 units (or 0.2 units/kg) once daily. The target fasting blood glucose was 70 to 130 mg/dL. Daily glargine dose was titrated by ±10% based on average of last 3 FBG values being out of target range and presence of nocturnal hypoglycemia. Early data trends: First interim analysis was planned once 100 subjects complete visit 8 (6 months treatment). By then, 119 subjects (78 males and 41 females) with mean age 46.3 years were enrolled, of which 90 (75.6%) subjects had evaluable data. The results of analysis indicated trend of comparability between Glaritus®and Lantus®at the end of 6 months in terms of immunogenicity (% change in AIA titre from baseline, −10.52 ± 23.06 vs. 0.48 ± 63.95), glycemic control (change in HbA1c from baseline, −1.09%

关键词： Insulin Antibodies Immunogenicity Insulin Glargine Biosimilar HbA1c

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