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J Comp Eff Res. 2020 Feb 6. doi: 10.2217/cer-2019-0136. [Epub ahead of print]

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

Author information

1
Institute of Endocrinology, Almazov National Medical Research Center, Saint-Petersburg, Russia.
2
Clinical Trials Department, OOO GEROPHARM, Saint-Petersburg, Russia.
3
Diabetes Prognosis and Innovation Department, Endocrinology Research Centre, Moscow, Russia.
4
Kazan Endocrine Center, Kazan, Russia.
5
Department of Endocrinology, First Pavlov State Medical University, Saint-Petersburg, Russia.
6
Clinical Pharmacology Department, Yaroslavl State Medical University, Yaroslavl, Russia.

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.

KEYWORDS:

GP40061; NCT02059187; biosimilar insulin; diabetes mellitus

PMID:
32027167
DOI:
10.2217/cer-2019-0136

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