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Research Article
6 February 2020

Safety and efficacy of GP40061 compared with originator insulin glargine (Lantus®): a randomized open-label clinical trial

Authors: Tatiana L Karonova, Anna A Mosikian [email protected], Alexander Y Mayorov, Igor E Makarenko, Svetlana T Zyangirova, Olena A Afonkina, Tatiana M Belikova, Alsu G Zalevskaya, Alexander L Khokhlov, and Roman V DraiAuthor Info & Affiliations
Volume 9, Number 4
https://doi.org/10.2217/cer-2019-0136
PDFFormats

Abstract

Aim: To compare safety (immunogenicity) and efficacy of GP40061 insulin glargine (GP-Gla) and Lantus® (Sanofi glargine, Sa-Gla) in people with diabetes mellitus. Materials & methods: This randomized open-label, 26-week clinical trial enrolled 180 Type 1 diabetes mellitus patients (HbA1c 6.5–12.0%), randomized 1:1 to once daily GP-Gla (n = 90) or Sa-Gla (n = 90). The primary end point was immune response at 26th week. Results: The frequency of immune response was similar in GP-Gla and Sa-Gla (p = 1.000). Groups were similar in terms of other safety end points. Mean HbA1c change from baseline was -0.66% for GP-Gla and -0.77% for Sa-Gla, and did not differ between groups (p = 0.326). Insulin doses, fasting plasma glucose and seven-point glucose profiles were similar between groups. Conclusion: GP-Gla and Sa-Gla demonstrated similar safety and efficacy.
ClinicalTrials.gov Identifier: NCT04022993

Supplementary Material

File (suppl_data.docx)

References

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