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Diabetes Care. 2015 Apr;38(4):637-43. doi: 10.2337/dc14-0006. Epub 2014 Aug 22.

New insulin glargine 300 Units · mL-1 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 Units · mL-1.

Author information

1
Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany reinhard.becker@sanofi.com.
2
Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.
3
Profil, Neuss, Germany.

Abstract

OBJECTIVE:

To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of a new insulin glargine comprising 300 units · mL(-1) (Gla-300), compared with insulin glargine 100 units · mL(-1) (Gla-100) at steady state in people with type 1 diabetes.

RESEARCH DESIGN AND METHODS:

A randomized, double-blind, crossover study (N = 30) was conducted, applying the euglycemic clamp technique over a period of 36 h. In this multiple-dose to steady-state study, participants received once-daily subcutaneous administrations of either 0.4 (cohort 1) or 0.6 units · kg(-1) (cohort 2) Gla-300 for 8 days in one treatment period and 0.4 units · kg(-1) Gla-100 for 8 days in the other. Here we focus on the results of a direct comparison between 0.4 units · kg(-1) of each treatment. PK and PD assessments performed on the last treatment day included serum insulin measurements using a radioimmunoassay and the automated euglycemic glucose clamp technique over 36 h.

RESULTS:

At steady state, insulin concentration (INS) and glucose infusion rate (GIR) profiles of Gla-300 were more constant and more evenly distributed over 24 h compared with those of Gla-100 and lasted longer, as supported by the later time (∼ 3 h) to 50% of the area under the serum INS and GIR time curves from time zero to 36 h post dosing. Tight blood glucose control (≤ 105 mg · dL(-1)) was maintained for approximately 5 h longer (median of 30 h) with Gla-300 compared with Gla-100.

CONCLUSIONS:

Gla-300 provides more even steady-state PK and PD profiles and a longer duration of action than Gla-100, extending blood glucose control well beyond 24 h.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01349855.

PMID:
25150159
DOI:
10.2337/dc14-0006
[Indexed for MEDLINE]

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