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- Title
Pharmacokinetic profiles of biphasic insulin aspart 30/70 and 70/30 in patients with Type 1 diabetes: a randomized double-blinded crossover study.
- Authors
Chen, J.-W.; Lauritzen, T.; Christiansen, J. J.; Jensen, L. H.; Clausen, W. H. O.; Christiansen, J. S.
- Abstract
To compare pharmacokinetic characteristics of two biphasic insulin aspart (BIAsp) formulations: BIAsp30 and BIAsp70 (30% and 70%, respectively, of fast-acting insulin aspart) during 15 days of multiple dosing (thrice daily).A total of 22 patients with Type 1 diabetes (nine women, 13 men) aged 41.4 ± 9.9 years (mean ± sd) with a diabetes duration of 18.9 (2.3–40.3) years (median and range) completed the randomized, double-blinded, two-period crossover study. On day 1 and day 15 of each treatment period, 24-h serum insulin and glucose profiles were evaluated. Total area under the insulin aspart concentration–time curve (AUC(0−24 h)), AUC after dinner administration stratified into early (AUCdinner(0−6 h)) and intermediate-phase (AUCdinner(6−14 h)), maximum insulin concentration (Cmax), time to maximum insulin concentration (Tmax) after each meal were recorded.On day 15 BIAsp70 was associated with a shorter Tmax, and more than 40% elevated Cmax. Comparing with BIAsp30, AUC(0−24 h) and AUCdinner(0−6 h) were increased by 25% and 28%, respectively, but AUCdinner (6−14 h) was markedly lower for BIAsp70[BIAsp30/BIAsp70: 1.9; 95% CI (1.42, 2.55)]. Similar findings were also observed on day 1. The fasting or pre-meal serum insulin levels on day 15 tended to be higher with BIAsp30, but the differences were not statistically significant.The pharmacokinetic properties of BIAsp30 and 70 remain constant during 2 weeks of daily administration in patients with Type 1 diabetes. In comparison with BIAsp30, the administration of BIAsp70 results in a shorter time to and larger maximum insulin aspart concentration. Furthermore, total and early post-dinner insulin AUC were greater, whereas late-phase insulin exposure was lower with BIAsp70.Diabet. Med. (2004)
- Subjects
PHARMACOKINETICS; INSULIN; TREATMENT of diabetes; BLOOD plasma; HYPOGLYCEMIC agents; PEOPLE with diabetes; PHARMACOLOGY
- Publication
Diabetic Medicine, 2005, Vol 22, Issue 3, p273
- ISSN
0742-3071
- Publication type
Article
- DOI
10.1111/j.1464-5491.2004.01404.x