title: Biphasic insulin aspart 30/70: pharmacokinetics and pharmacodynamics compared with once-daily biphasic human insulin and Basal-bolus therapy.
abstract: OBJECTIVE Pharmacological profiles of biphasic insulin aspart 30/70 (BIAsp 30) once daily (OD), twice daily (b.i.d.), and three times daily (t.i.d.) were compared with other insulin regimens in two crossover glucose clamp studies of insulin-treated type 2 diabetic patients. RESEARCH DESIGNS AND METHODS Study 1 consisted of BIAsp 30 OD, b.i.d., and t.i.d. versus biphasic human insulin 30/70 (BHI 30), OD (n = 24). Study 2 examined BIAsp 30 t.i.d. versus basal-bolus therapy (insulin glargine OD plus insulin glulisine t.i.d.) (n = 24). Pharmacokinetics/pharmacodynamics (PK/PD) were investigated over 24 h. RESULTS Study 1: PK and PD were markedly different between BIAsp 30 OD and BHI 30 OD: the maximum insulin concentration and glucose infusion rate (GIR) were higher for BIAsp 30; time to maximum metabolism was 1.7 h sooner for BIAsp 30. Study 2: both regimens showed three distinct prandial-related GIR peaks. GIR 24-h area under the curve for BIAsp t.i.d. was higher than for basal-bolus therapy: 2,585.2 vs. 2,289.2 mg/kg. CONCLUSIONS BIAsp had pharmacological advantages over BHI. BIAsp t.i.d. had a similar PD profile to basal-bolus therapy.
authors.affiliation: Profil Institut für Stoffwechselforschung, Neuss, Germany. tim.heise@profil-research.de
authors.forename: Tim
authors.initials: T
authors.lastname: Heise
authors.forename: Lutz
authors.initials: L
authors.lastname: Heinemann
authors.forename: Ulrike
authors.initials: U
authors.lastname: Hövelmann
authors.forename: Bianca
authors.initials: B
authors.lastname: Brauns
authors.forename: Leszek
authors.initials: L
authors.lastname: Nosek
authors.forename: Hanne L
authors.initials: HL
authors.lastname: Haahr
authors.forename: Klaus J
authors.initials: KJ
authors.lastname: Olsen
mesh_terms: D000284:Administration, Oral; D061265:Biphasic Insulins; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D018592:Cross-Over Studies; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004334:Drug Administration Schedule; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D007328:Insulin / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use; D061267:Insulin Aspart; D000069036:Insulin Glargine; D007336:Insulin, Isophane; D049528:Insulin, Long-Acting; D011897:Random Allocation
chemical_list: D061265:Biphasic Insulins; D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin; D049528:Insulin, Long-Acting; C557564:insulin aspart, insulin aspart protamine drug combination 30:70; D000069036:Insulin Glargine; D007336:Insulin, Isophane; C479079:insulin glulisine; D061267:Insulin Aspart