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

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 admin...

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Bibliographic Details
Published in:Diabetes, obesity & metabolism obesity & metabolism, 2015-03, Vol.17 (3), p.261-267
Main Authors: Becker, R. H. A., Nowotny, I., Teichert, L., Bergmann, K., Kapitza, C.
Format: Article
Language:English
Subjects:
Adolescent
Adult
Blood Glucose - drug effects
Blood Glucose - metabolism
Confidence intervals
Cross-Over Studies
Diabetes
Diabetes mellitus (insulin dependent)
Diabetes Mellitus, Type 1 - blood
Diabetes Mellitus, Type 1 - drug therapy
Double-Blind Method
Drug Administration Schedule
Female
Glucose Clamp Technique - methods
Humans
Hypoglycemic Agents - administration & dosage
Hypoglycemic Agents - blood
Hypoglycemic Agents - pharmacokinetics
Insulin
Insulin Glargine
Insulin, Long-Acting - administration & dosage
Insulin, Long-Acting - blood
Insulin, Long-Acting - pharmacokinetics
Male
Metabolism
Middle Aged
Original
pharmacokinetics
Reproducibility
Reproducibility of Results
Therapeutic Equivalency
type 1 diabetes
Young Adult
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Summary: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. Results The cumulative exposure and effect of Gla‐300 developed linearly over 24 h, and were evenly distributed across 6‐ and 12‐h intervals. Diurnal fluctuation in exposure (within‐day variability) was low; the peak‐to‐trough ratio of insulin concentration profiles was
ISSN:1462-8902
1463-1326
DOI:10.1111/dom.12416