Journals Information
Advances in Diabetes and Metabolism(CEASE PUBLICATION) Vol. 8(1), pp. 1 - 10
DOI: 10.13189/adm.2020.080101
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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: Results of Interim Analysis
S. K. Sharma 1,*, A. K. Ajmani 2, P. Khosla 3, P. Mukhopadhyay 4, G. Bhatia 5, K. G. Prakash 6, G. Chhaya 7, P. D. Supe 8, V. Pavithran 9, H. Bora 10, S. Ingole 11, R. Jain 11
1 Department of Endocrinology, Diabetes Thyroid & Endocrine Centre, Jaipur, Rajasthan, India
2 Department of Endocrinology, BL Kapur Super Speciality Hospital, New Delhi, India
3 Department of Medicine, Sir Ganga Ram Hospital, New Delhi, India
4 Department of Endocrinology, Faculty of Medicine, Institute of Post Graduate Medical Education & Research & SSKM Hospital, Kolkata, West Bengal, India
5 Department of Medicine, Medipoint Hospitals Pvt. Ltd. Pune, Maharashtra, India
6 Department of Medicine, Faculty of Medicine, Bangalore Medical College & Research Institute, Bangalore, India
7 Department of Diabetology, Sanjivani Superspeciality Hospital Pvt. Ltd., Ahmedabad, Gujarat, India
8 Department of Medicine, Supe Heart & Diabetes Hospital & Research Centre, Nashik, Maharashtra, India
9 Department of Medicine, KVM Hospital, Cherthala, Alappuzha, Kerala, India
10 Department of Medicine, Downtown Hospital, Guwahati, Assam, India
11 Department of Medical Affairs, Wockhardt Ltd., Mumbai, Maharashtra, India
ABSTRACT
Objective: To compare the change in immunogenic response, safety and efficacy of insulin glargine in Glaritus® and Lantus® treatment arms from baseline to six months in patients with type 2 diabetes mellitus (T2DM) uncontrolled on oral antidiabetic drugs (OADs). Material and methods: In an ongoing prospective, open-label, randomized, parallel-group, comparative, multicenter, phase IV study, adult patients with uncontrolled T2DM are treated with either Glaritus® once daily or Lantus® once daily for six months, both given subcutaneously. Glaritus® treatment arm is to be continued for another six months. The primary endpoint for the study was the percentage change in anti-insulin antibodies (AIA) titer to glargine in both treatment arms from baseline to six months. Results: Ninety patients were randomized to each group. Baseline characteristics were comparable between the groups (p>0.05). There was no significant difference in percent change in the AIA titer between the two treatment arms at the end of six months in ITT (intent-to-treat) and mITT(modified intent to treat) population (LS mean diff [95% CI]: 2.2% (-15.1%, 19.6%), p=0.7987 and 3.4% (-15.1%, 21.9%), p=0.7181, respectively). No significant between-group difference was seen in change in the HbA1c level at the end of six months in ITT and mITT population [LS mean diff (95% CI): -0.2 (-0.4, 0.0), p=0.1072 for ITT population; and -0.1 (-0.3, 0.1), p=0.2283, for mITT population]. There was also no significant difference between two groups for the incidence of adverse events [Glaritus® 17 (18.9%) and Lantus® 20 (22.2%) p=0.5800]. Conclusion: Glaritus® was found to be non-inferior to Lantus® in glycaemic control and comparable in immunogenic response and safety at the end of six months in patients with T2DM uncontrolled on OADs.
KEYWORDS
Immunogenicity, Insulin Glargine, Glaritus®, Lantus®, Type 2 Diabetes Mellitus
Cite This Paper in IEEE or APA Citation Styles
(a). IEEE Format:
[1] S. K. Sharma , A. K. Ajmani , P. Khosla , P. Mukhopadhyay , G. Bhatia , K. G. Prakash , G. Chhaya , P. D. Supe , V. Pavithran , H. Bora , S. Ingole , R. Jain , "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: Results of Interim Analysis," Advances in Diabetes and Metabolism(CEASE PUBLICATION), Vol. 8, No. 1, pp. 1 - 10, 2020. DOI: 10.13189/adm.2020.080101.
(b). APA Format:
S. K. Sharma , A. K. Ajmani , P. Khosla , P. Mukhopadhyay , G. Bhatia , K. G. Prakash , G. Chhaya , P. D. Supe , V. Pavithran , H. Bora , S. Ingole , R. Jain (2020). 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: Results of Interim Analysis. Advances in Diabetes and Metabolism(CEASE PUBLICATION), 8(1), 1 - 10. DOI: 10.13189/adm.2020.080101.