title: Postprandial glycemic control with biphasic insulin aspart in patients with type 1 diabetes.
abstract: We sought to investigate the ability of biphasic insulin aspart 30 (BIAsp 30) to control postprandial hyperglycemia and hyperlipidemia in a meal-test comparison with biphasic human insulin 30 (BHI 30). In this randomised crossover trial, 50 patients with type 1 diabetes (mean age, 35.7 +/- 9.4 years; body mass index [BMI], 24.0 +/- 2.6 kg/m(2); HbA(1c), 8.6% +/- 1.1%) were studied on 3 separate days, where the following treatments were given in random order: BIAsp 30 injected immediately before a standard breakfast, BHI 30 injected 30 minutes before breakfast (BHI 30(t=-30)), and BHI 30 injected immediately before breakfast (BHI 30(t=0)). The dose was 0.40 U/kg for all 3 treatments. BIAsp 30 reduced the area under the baseline adjusted 4-hour postprandial serum glucose curve (AUC(0-4h)) by 23% compared with BHI 30(t=0) (P <.0001) and by 9% compared with BHI 30(t=-30) (P =.013). Maximum serum glucose concentration (C(max)) was lower for BIAsp 30 compared with BHI 30(t=0) (14.0 +/- 2.4 v 16.5 +/- 2.8 mmol/L, P <.0001), and time to maximal serum glucose concentration (t(max)) was approximately 20 minutes shorter for BIAsp 30, irrespective of timing of BHI 30 injection (P <.0001). There were no significant differences among the 3 treatments with respect to postprandial levels of free fatty acids or triglycerides. The pharmacokinetic results were consistent with the above observations, ie, significantly larger insulin AUC(0-4h), higher C(max) and shorter t(max) were observed for BIAsp 30 compared with BHI 30, irrespective of timing of BHI 30 injection. We conclude that postprandial glycemic control was more effective with BIAsp 30 than with BHI 30, irrespective of timing of BHI 30 injection.
authors.affiliation: University Department of Endocrinology and Metabolism, Arhus Amtssygehus, Arhus, Denmark.
authors.forename: Kjeld
authors.initials: K
authors.lastname: Hermansen
authors.forename: Stein
authors.initials: S
authors.lastname: Vaaler
authors.forename: Sten
authors.initials: S
authors.lastname: Madsbad
authors.forename: Marian
authors.initials: M
authors.lastname: Dalgaard
authors.forename: Mette
authors.initials: M
authors.lastname: Zander
authors.forename: Kamilla
authors.initials: K
authors.lastname: Begtrup
authors.forename: Karsten
authors.initials: K
authors.lastname: Soendergaard
mesh_terms: D000328:Adult; D019540:Area Under Curve; D061265:Biphasic Insulins; D001786:Blood Glucose / Q000187:drug effects*; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004304:Dosage Forms; D005230:Fatty Acids, Nonesterified / Q000097:blood; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D007279:Injections, Subcutaneous; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives / Q000493:pharmacokinetics; D061267:Insulin Aspart; D007336:Insulin, Isophane; D019518:Postprandial Period / Q000187:drug effects*; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
chemical_list: D061265:Biphasic Insulins; D001786:Blood Glucose; D004304:Dosage Forms; D005230:Fatty Acids, Nonesterified; D007004:Hypoglycemic Agents; D007328:Insulin; D014280:Triglycerides; C557564:insulin aspart, insulin aspart protamine drug combination 30:70; D007336:Insulin, Isophane; D061267:Insulin Aspart