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
| Autor: | K. G. Prakash, G. Bhatia, S. Ingole, P. Khosla, P. Mukhopadhyay, Rishi Jain, G. Chhaya, H. Bora, V. Pavithran, S. K. Sharma, P. D. Supe, A. K. Ajmani |
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| Rok vydání: | 2020 |
| Předmět: |
Embryology
education.field_of_study medicine.medical_specialty Intention-to-treat analysis Insulin glargine business.industry Incidence (epidemiology) Population Type 2 Diabetes Mellitus Cell Biology Interim analysis Internal medicine Clinical endpoint medicine Anatomy Adverse effect education business Developmental Biology medicine.drug |
| Zdroj: | Advances in Diabetes and Metabolism. 8:1-10 |
| ISSN: | 2332-0060 2332-0052 |
| DOI: | 10.13189/adm.2020.080101 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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