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  

Oleh:

Becker, Reinhard H.A. ; Dahmen, Raphael ; Bergmann, Karin ; Lehmann, Anne ; Jax, Thomas ; Heise, Tim

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Diabetes Care vol. 38 no. 04 (Apr. 2015), page 637-643 .

Ketersediaan

Perpustakaan FK Nomor Panggil: D05.K Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

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.

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