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Randomized Controlled Trial
. 2011 Mar;13(3):251-7.
doi: 10.1111/j.1463-1326.2010.01343.x.

Comparative pharmacodynamic and pharmacokinetic characteristics of subcutaneous insulin glulisine and insulin aspart prior to a standard meal in obese subjects with type 2 diabetes

G B Bolli  1 , S Luzio, S Marzotti, F Porcellati, C Sert-Langeron, B Charbonnel, Y Zair, D R Owens
Affiliations
Free PMC article
Randomized Controlled Trial

Comparative pharmacodynamic and pharmacokinetic characteristics of subcutaneous insulin glulisine and insulin aspart prior to a standard meal in obese subjects with type 2 diabetes

G B Bolli et al. Diabetes Obes Metab. 2011 Mar.
Free PMC article

Abstract

Aims: A multinational, randomized, double-blind, two-way crossover trial to compare the pharmacokinetic and pharmacodynamic properties of bolus, subcutaneously administered insulin glulisine (glulisine) and insulin aspart (aspart) in insulin-naÏve, obese subjects with type 2 diabetes.

Methods: Thirty subjects [9/21 females/males; mean ± SD age: 60.7 ± 7.7 years; body mass index (BMI): 33.5 ± 3.3 kg/m(2) ; duration of diabetes: 6.8 ± 4.6 years; HbA1c: 7.1 ± 0.8%] were included in the analysis. They fasted overnight and then received a 0.2 U/kg subcutaneous dose of glulisine or aspart 2 min before starting a standardized test meal, 7 days apart, according to a randomization schedule. Blood samples were taken every 15 min, starting 20 min before the meal and ending 6 h postprandially.

Results: The area under the absolute glucose concentration-time curve between 0 and 1 h after insulin injection and maximal glucose concentration was significantly lower with glulisine than with aspart (p = 0.0455 and 0.0337, respectively). However, for the total study period, plasma glucose concentration was similar for glulisine and aspart. Peak insulin concentration was significantly higher for glulisine than for insulin aspart (p < 0.0001). Hypoglycaemic events (≤ 70 mg/dl with or without symptoms) occurred in 13 and 16 subjects treated with glulisine and aspart, respectively, but there were no cases of severe hypoglycaemia requiring intervention.

Conclusions: Glulisine was associated with lower glucose levels during the first hour after a standard meal; the remaining glucose profiles were otherwise equivalent, with higher insulin levels observed throughout the study period.

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Figures

Figure 1
Figure 1
Mean plasma glucose concentrations over time. SEM, standard error of the mean.
Figure 2
Figure 2
(a) Mean plasma insulin concentrations over time and (b) mean plasma insulin concentrations in percentage of peak insulin concentration over time. *p < 0.001 compared with insulin aspart at 10 min and † p > 0.001 compared with insulin aspart at 20 min. SEM, standard of the mean; Cmax, peak insulin concentration.
See this image and copyright information in PMC

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