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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.

Investigational new insulin glargine 300 U/ml has the same metabolism as insulin glargine 100 U/ml