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Investigational new insulin glargine 300 U/ml has the same metabolism as insulin glargine 100 U/ml
Author(s) -
Steinstraesser A.,
Schmidt R.,
Bergmann K.,
Dahmen R.,
Becker R. H. A.
Publication year - 2014
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12283
Subject(s) - insulin glargine , insulin , pharmacokinetics , chemistry , metabolism , endocrinology , metabolite , medicine , pharmacology , hypoglycemia
Insulin glargine is processed in vivo into soluble 21 A ‐Gly‐human insulin ( M1 ), the principal moiety responsible for metabolic effects, and subsequently into M2 . This sub‐study compared metabolism and metabolite pharmacokinetic (PK) profiles of investigational new insulin glargine U300 (Gla‐300) with insulin glargine 100 U/ml (Gla‐100, Lantus®, Sanofi‐Aventis Deutschland GmbH, Frankfurt am Main, Germany) in people with type 1 diabetes. Participants received 0.4 (n = 18) or 0.6 U/kg Gla‐300 (n = 12), and 0.4 U/kg Gla‐100 (n = 30) once daily in randomized order for 8 days prior to a 36‐h euglycaemic clamp. Metabolites were quantified using immunoaffinity enrichment and liquid chromatography tandem mass spectrometry ( LC‐MS / MS ). Glargine metabolism was the same regardless of Gla‐100 or Gla‐300 administration; M1 was confirmed as the principal active moiety circulating in blood. Steady state concentrations of M1 were achieved after 2 days for Gla‐100, and 4 days for Gla‐300. Steady state M1 values defined prolonged and even flatter PK profiles after Gla‐300 administration compared with M1 profiles after Gla‐100.