 Patients with type 1 diabetes mellitus for more than one year, aged between 18 and 60 years; on intensive insulin therapy by means of CSII continuous subcutaneous insulin infusion or MDI multiple daily injections for at least 6 months before screening; glycosylated haemoglobin of 6-8.5; without severe chronic micro- and macroangiopathic diabetic complications and with a body mass index BMI between 18 and 30 kgm2. 