Biphasic insulin aspart 30/70: pharmacokinetics and pharmacodynamics compared with once-daily biphasic human insulin and Basal-bolus therapy

Tim Heise, Lutz Heinemann, Ulrike Hövelmann, Bianca Brauns, Leszek Nosek, Hanne L Haahr, Klaus J Olsen, Tim Heise, Lutz Heinemann, Ulrike Hövelmann, Bianca Brauns, Leszek Nosek, Hanne L Haahr, Klaus J Olsen

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.

Figures

Figure 1
Figure 1
PK and PD profiles following injections of test insulins in two studies in patients with type 2 diabetes, obtained using a euglycemic clamp procedure. A: Study 1: 24-h serum insulin profiles during which patients received BIAsp 30 once (1900 h), twice (0700 and 1900 h), or three times (0700, 1300, and 1900 h) daily, or BHI 30 once daily (1900 h). The 24-h profiles have been overlain for ease of comparison. B: Study 1: 24-h GIR profiles during which patients received BIAsp 30 once (1900 h), twice (0700 and 1900 h), or three times (0700, 1300, and 1900 h) daily, or BHI 30 once daily (1900 h). The 24-h profiles have been overlain for ease of comparison. C: Study 2: 24-h GIR profiles during which patients received BIAsp 30 three times daily (0700, 1300, and 1900 h) or basal-bolus therapy using insulin glargine once daily (2300 h on the day before the clamp and again on the day of the clamp) plus insulin glulisine three times daily (0700, 1300, and 1900 h).

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