Lispro is a human
insulin analogue with a very rapid onset of action, and a shorter duration of activity than
soluble insulin. In order to assess the therapeutical value of
lispro, we have had an open-label, non-comparative study, for 12 weeks, involving 19
IDDM patients. The treatment regimen with
lispro and
Humulin N has been adapted depending on each patient characteristics. Patients attended three visits, and the main metabolic control parameters included values of
hemoglobin Alc, fasting and postprandial
blood glucose monitoring. The patients themselves monitored their
blood glucose using a glucometer. The mean age value of 19 patients (8 females and 11 males) was 22.32 (+/- 13.59) years. In patients previously receiving
insulin treatment,
therapy with
lispro insulin significantly reduced postprandial
glucose values.
Lispro has been administered t.i.d. in 14 patients, and b.i.d. in 5 patients. At visit 1, mean value of HbAlc was 10.32% (+/- 1.63%); at visit 3, mean HbAlc was 9.90% (+/- 1.59%). Total
insulin daily dose and the rate of short and
long acting insulin did not change from visit 1 to visit 3. There has been reported only one serious adverse event during the study: a
ketoacidosis due to a technical dosing error. Ten patients have reported mild
hypoglycemic episodes. The outcomes of clinical study and of Quality of Life Questionnaire suggests that
lispro--the first human
insulin analogue used in humans--is effective, safe, and it is broadening beneficially the spectrum of
insulins.