Low within- and between-day variability in exposure to new insulin glargine 300 U/ml.

ABSTRACT:

Aims

To characterize the variability in exposure and metabolic effect of insulin glargine 300 U/ml (Gla-300) at steady state in people with type 1 diabetes (T1DM).

Methods

A total of 50 participants with T1DM underwent two 24-h euglycaemic clamps in steady-state conditions after six once-daily administrations of 0.4 U/kg Gla-300 in a double-blind, randomized, two-treatment, two-period, crossover clamp study. Participants were randomized to receive Gla-300 as a standard cartridge formulation in the first treatment period, and as a formulation with enhanced stability through polysorbate-20 addition in the second treatment period, or vice versa. This design allowed the assessment of bioequivalence between formulations and, subsequently, within- and between-day variability.

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SUBMITTER: Becker RH 

PROVIDER: S-EPMC4674964 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature