Background: Insulin lispro (Humalog®)) is an insulin-analogue which mimics the insulin kinetics better than human regular insulin. Methods: To assess the safety and the efficacy of insulin lispro (Humalog®) 123 type 1 patients (63 men, 60 women, age: 34.9±9.3 years; duration of diabetes 11.7±8.2 years; duration of intensive conservative insulin therapy 4.8±4.0 years; x±SD) were investigated in an open, 16 week-long, multicenter study in Hungary. Safety of the treatment with insulin lispro was evaluated by registration of adverse events and numbers of hypoglycaemic episodes (blood glucose <2.5 mmol/l with or without symptoms) while efficacy was assessed by measuring HbA(1c) values and blood glucose home monitoring. Self assessment of lifestyle was evaluated by a questionnaire. Following the recruitment period, type 1 patients were treated for 4 weeks with human unmodified regular insulin (Humulin R®) given 15-30 min before meals (3 times daily) and basal insulin (Humulin N®) twice daily. Subsequently, patients were switched to insulin lispro (Humalog®) given immediately before meals with unchanged basal insulin supplementation for 12 weeks. Results: Only one, obviously unrelated adverse event (tibial fracture) was reported during lispro treatment-period. The number of hypoglycaemic episodes did not differ significantly (p=0.61) during human unmodified regular insulin period (170 episodes in 4 weeks = 0.34 episode/week/patient) compared to that of insulin lispro period (565 episodes in 12 weeks = 0.38 episode/week/patient). The postprandial (90 min after breakfast) blood glucose values were significantly (p=0.0026) lower (8.1±2.4 mmol/l) during lispro treatment compared to those during human unmodified regular insulin therapy (8.8±2.2 mmol/l). The postprandial blood glucose changes were significantly smaller at breakfast and dinner during lispro than human unmodified regular insulin treatment (at breakfast: -0.2±2.7 mmol/l vs +0.7±2.3 mmol/l, p<0.001; at dinner: +0.2±2.4 mmol/l vs +0.8±2.1 mmol/l, p=0.021). The HbA(1c) values were significantly (p=0.031) lower at the end (7.59±1.38%) than at the beginning (7.77±1.49%) of treatment with insulin lispro. According to the patients' questionnaires, more flexible lifestyle was the most common declared benefit related to the use of insulin lispro treatment. Nearly all patient (n=115: 93.5 %) preferred to continue insulin lispro therapy at the end of the study. Conclusions: The efficacy as well as the safety of insulin lispro treatment were documented and, in addition, some advantages in the social aspects of daily life were recorded during insulin lispro treatment in a relatively large number of type 1 patients in Hungary.
|Number of pages||7|
|Publication status||Published - dec. 1 1999|
ASJC Scopus subject areas
- Internal Medicine
- Endocrinology, Diabetes and Metabolism