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Diabetes Metab. 2018 Feb;44(1):15-21. doi: 10.1016/j.diabet.2017.10.001. Epub 2017 Nov 16.

Morning administration of 0.4U/kg/day insulin glargine 300U/mL provides less fluctuating 24-hour pharmacodynamics and more even pharmacokinetic profiles compared with insulin degludec 100U/mL in type 1 diabetes.

Author information

1
AMCR Institute, 625 West Citracado Parkway Suite 112, Escondido, California 92025, USA. Electronic address: tbailey@amcrinstitute.com.
2
University of California, San Diego, CA, USA.
3
Inserm U1138, Centre de Recherche des Cordeliers, 75006 Paris, France; Université Paris Diderot, Sorbonne Paris Cité, 75013 Paris, France; Diabetology, Endocrinology and Nutrition Department, DHU FIRE, Hôpital Bichat, AP-HP, 75018 Paris, France.
4
Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.
5
Umanis, Levallois-Perret, 92300 France.
6
Profil, Neuss, Germany.
7
Department of Medicine, University of Perugia Medical School, Perugia, Italy.

Abstract

AIM:

To compare steady state pharmacodynamic and pharmacokinetic profiles of insulin glargine 300U/mL (Gla-300) with insulin degludec 100U/mL (Deg-100) in people with type 1 diabetes.

METHODS:

This single-centre, randomized, double-blind crossover euglycaemic clamp study included two parallel cohorts with fixed once-daily morning dose regimens. For both insulins participants received 0.4 (n=24) or 0.6U/kg/day (n=24), before breakfast, for 8 days prior to the clamp. The main endpoint was within-day variability (fluctuation) of the smoothed glucose infusion rate (GIR) over 24 hours (GIR-smFL0-24).

RESULTS:

Gla-300 provided 20% less fluctuation of steady state glucose infusion rate profiles than Deg-100 over 24 hours at 0.4U/kg/day (GIR-smFL0-24 treatment ratio 0.80 [90% confidence interval: 0.66 to 0.96], P=0.047), while at the dose of 0.6U/kg/day the difference between insulins was not statistically significant (treatment ratio 0.96 [0.83 to 1.11], P=0.603). Serum insulin concentrations appeared more evenly distributed with both dose levels of Gla-300 versus the same doses of Deg-100, as assessed by relative 6-hour fractions of the area under the curve within 24 hours. Both insulins provided exposure and activity until 30 hours (end of clamp).

CONCLUSION:

Gla-300 provides less fluctuating steady state pharmacodynamic profiles (i.e. lower within-day variability) and more evenly distributed pharmacokinetic profiles, compared with Deg-100 in a once-daily morning dosing regimen of 0.4U/kg/day.

KEYWORDS:

Insulin degludec; Insulin glargine; Pharmacodynamic; Pharmacokinetic; Type 1 diabetes

PMID:
29153485
DOI:
10.1016/j.diabet.2017.10.001
[Indexed for MEDLINE]
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