A Direct Comparison of Insulin Aspart and Insulin Lispro in Patients With Type 1 Diabetes

Abstract

OBJECTIVE -Both rapid-acting insulin analogs, insulin aspart and lispro, attenuate prandial glucose excursion compared with human soluble insulin. This trial was performed to study the pharmacokinetic and pharmacodynamic profiles of insulin aspart and insulin lispro in type 1 diabetic patients in a direct comparison and to investigate whether the administration of one analog results in favorable effects on prandial blood glucose control. RESEARCH DESIGN AND METHODS-A total of 24 type 1 diabetic patients (age 36 Ϯ 8 years, 16 men and 8 women, BMI 24.3 Ϯ 2.6 kg/m 2 , diabetes duration 17 Ϯ 11 years, HbA 1c 7.9 Ϯ 0.8%) on intensified insulin therapy were recruited into a single-center, randomized, double-blind, two-period, cross-over, glucose clamp trial. The subjects were given an individual need-derived dose of prandial insulin lispro or aspart immediately before a standard mixed meal.RESULTS -With respect to blood glucose excursions from time 0 to 6 h (Exc glu(0 -6 h) ) and from time 0 to 4 h (Exc glu(0 -4 h) ), the pharmacodynamic effect of insulin aspart and insulin lispro can be declared equivalent. This was supported by comparison with maximum postprandial blood glucose excursions (C max(glu) glu(0 -6 h) , Exc glu(0 -4 h) , and C max(glu) , respectively). For pharmacokinetic end points (maximum postprandial insulin excursions and area under the curve for insulin from time 0 to 6 h and from time 0 to 4 h), equivalence was indicated. No difference concerning absorption or elimination for time to maximal insulin concentration, time to half-maximum insulin concentration, and time to decrease to 50% of maximum insulin concentration was observed.CONCLUSIONS -These data suggest that in type 1 diabetic patients, both insulin analogs are equally effective for control of postprandial blood glucose excursions. Diabetes Care 25:2053-2057, 2002I n accordance with the results of the Diabetes Control and Complication Trial, near-normoglycemic blood glucose levels prevent the onset or delay the progression of long-term complications in type 1 diabetes (1). To mimic the physiological insulin secretion profile, intensified insulin therapy with unmodified human soluble insulin is performed as standard treatment regimen by a majority of patients (2,3). However, postprandial blood glucose peaks and excursions are not comparable with nondiabetic subjects. Absorption of unmodified insulin from the injection site is a complex process affected by only partially changeable factors, such as anatomic area, blood flow, injection volume, concentration of insulin, and possible local degradation process (4 -6). Therefore, considerable attention has been devoted to the development of insulin molecules with accelerated absorption kinetics (7-9). This more physiological profile of these shortacting insulin analogs leads to reduced prandial glucose excursions (10 -13). In well-controlled type 1 diabetic patients, postprandial administration of insulin aspart and insulin lispro has shown to be at least as effective as mealtime application o...

Meta-analysis of short-acting insulin analogues in adult patients with type 1 diabetes: continuous subcutaneous insulin infusion versus injection therapy

“…This effect was negligible in patients in IIT studies. We did not differentiate between the SAI analogues lispro and aspart because it is known that both insulin analogues are equally effective at controlling prandial blood glucose fluctuations in type 1 diabetic patients [55,56].…”

Insulin Analogs: Impact on Treatment Success, Satisfaction, Quality of Life, and Adherence

“…A double-blind, two-period, crossover trial comparing insulin aspart and insulin lispro found no differences between them with regard to maximal insulin concentration, time to half-maximum insulin concentration, and time to 50% decrease of maximum insulin concentration. 23 In a study of obese subjects without diabetes, insulin glulisine and insulin lispro were found to have similar, more rapid time-action profiles compared to human insulin, a difference that prevailed regardless of body mass index and subcutaneous fat thickness. 24 However, in a randomized, double-blind, crossover study on lean to obese subjects without diabetes, insulin glulisine showed a somewhat greater early metabolic action than insulin lispro, an effect that was independent of body mass index and dose.…”

Insulinothérapie Nouvelles molécules et voies d’administration

“…En accord avec le profil pharmacodynamique de l'insuline aspart, les données cliniques disponibles montrent que son injection immédiatement avant le repas réduit significativement les oscillations de la glycémie postprandiale, de façon plus importante que l'injection d'insuline 30 minutes avant le repas. Récemment, une comparaison directe de la capacité des formes aspart et lispro à contrôler la glycémie chez des patients diabétiques de type 1 a montré que les deux analogues entraînent une diminution de la glycémie postprandiale (rapport aspart/lispro des Cmax pour les oscillations de la glycémie postprandiale = 1,01) [20]. Deux études réalisées à grande échelle [21,22] ont également montré une diminution faible, mais statistiquement significative, du pourcentage d'HbA1c (environ 0,15% d'HbA1c) après traitement par l'insuline aspart, par rapport à l'insuline humaine.…”