Pharmacokinetic and pharmacodynamic bioequivalence of Gan & Lee insulin analogues aspart (rapilin®), lispro (prandilin®) and glargine (basalin®) with EU- und US-sourced reference insulins.
Male
Humans
United States
Insulin Glargine
/ adverse effects
Insulin Lispro
/ therapeutic use
Insulin
Hypoglycemic Agents
/ therapeutic use
Therapeutic Equivalency
Biosimilar Pharmaceuticals
/ therapeutic use
Blood Glucose
Insulin, Regular, Human
Cross-Over Studies
Double-Blind Method
Insulin Aspart
/ adverse effects
bioequivalence
insulin aspart
insulin glargine
insulin lispro
pharmacodynamics
pharmacokinetics
Journal
Diabetes, obesity & metabolism
ISSN: 1463-1326
Titre abrégé: Diabetes Obes Metab
Pays: England
ID NLM: 100883645
Informations de publication
Date de publication:
12 2023
12 2023
Historique:
revised:
21
08
2023
received:
04
07
2023
accepted:
28
08
2023
medline:
13
11
2023
pubmed:
22
9
2023
entrez:
22
9
2023
Statut:
ppublish
Résumé
For the successful approval and clinical prescription of insulin biosimilars, it is essential to show pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to the respective reference products sourced from the European Union and the United States. Three phase 1, randomized, double-blind, three-period crossover trials compared single doses of the proposed biosimilar insulin analogues aspart (GL-Asp, n = 36), lispro (GL-Lis, n = 38) and glargine (GL-Gla, n = 113), all manufactured by Gan & Lee pharmaceuticals, to the respective EU- and US-reference products in healthy male participants (GL-Asp and GL-Lis) or people with type 1 diabetes (GL-Gla). Study participants received 0.2 U/kg (aspart and lispro) or 0.5 U/kg (glargine) of each treatment under automated euglycaemic clamp conditions. The clamp duration was 12 h (aspart and lispro) or 30 h (glargine). Primary PK endpoints were the total area under the PK curves (AUC Bioequivalence to both EU- and US-reference products were shown for all three GL insulins. Least squares mean ratios for the primary PK/PD endpoints were close to 100%, and both 90% and 95% confidence intervals were within 80%-125% in all three studies. There were no noticeable differences in the safety profiles between test and reference insulins, and no serious adverse events were reported for the GL insulins. GL-Asp, GL-Lis and GL-Gla are bioequivalent to their EU- and US-reference products.
Substances chimiques
Insulin Glargine
2ZM8CX04RZ
Insulin Lispro
0
Insulin
0
fluchloralin
98UIF19AH9
Hypoglycemic Agents
0
Biosimilar Pharmaceuticals
0
Blood Glucose
0
Insulin, Regular, Human
0
Insulin Aspart
D933668QVX
Banques de données
ClinicalTrials.gov
['NCT04237129', 'NCT04235439', 'NCT04236895']
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
3817-3825Informations de copyright
© 2023 John Wiley & Sons Ltd.
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