Author(s)

S. K. Sharma¹, A. K. Ajmani², P. Khosla³, P. Mukhopadhyay⁴, G. Bhatia⁵, K. G. Prakash⁶, G. Chhaya⁷, P. D. Supe⁸, V. Pavithran⁹, H. Bora¹⁰, R. Jain¹¹, S. Ingole¹¹, A. Shah¹¹

¹Diabetes, Thyroid and Endocrine Centre, Jaipur, India.
²BL Kapoor Hospital, Delhi, India.
³Sir Ganga Ram Hospital, Delhi, India.
⁴Institute of Post Graduate Medical Education and Research, Kolkata, India.
⁵Medipoint Hospitals Pvt. Ltd., Pune, India.
⁶Bangalore Medical College and Research Institute, Bangalore, India.
⁷Sanjivani Supers Peciality Hospital, Ahmedabad, India.
⁸Supe Heart and Diabetes Hospital and Research Centre, Nashik, India.
⁹KVM Hospital, Kerala, India.
¹⁰Downtown Hospital, Guwahati, India.
¹¹Wockhardt 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% ± 1.29% vs. 0.63% ± 1.19%) and hypoglycemic events (reported by 1 vs. 2 patients), respectively. Conclusion: The present study represents a robust design in line with international guidelines on biosimilar insulin development and the early data trends presents expected similarity of Glaritus® in immunogenicity, efficacy and safety to that of Lantus® in treatment of T2DM.

Insulin Antibodies, Immunogenicity, Insulin Glargine, Biosimilar, HbA1c

Sharma, S. , Ajmani, A. , Khosla, P. , Mukhopadhyay, P. , Bhatia, G. , Prakash, K. , Chhaya, G. , Supe, P. , Pavithran, V. , Bora, H. , Jain, R. , Ingole, S. and Shah, A. (2018) Immunogenicity, Safety and Efficacy Comparison of Wockhardt’s Biosimilar Insulin Glargine—Glaritus® with Reference Product— Lantus®: Study Protocol & Early Data Trends. Open Journal of Endocrine and Metabolic Diseases, 8, 157-166. doi: 10.4236/ojemd.2018.88016.