Examining the Long-term Safety of Insulin Aspart When Used as a Part of the Treatment for Type 1 Diabetes

An Open-labelled, Non-randomized, Multi-centre, Multinational Extension Trial Assessing the Safety of Insulin Aspart in Patients With Type I Diabetes Treated With a Basal-bolus Regimen

This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the long-term safety of insulin aspart in the management of type 1 diabetes. An extension to the ANA/DCD/065 trial

Inclusion Criteria:

• Signed informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
• The subject must have completed the ANA/DCD/065 trial

Exclusion Criteria:

• Impaired hepatic function
• Impaired renal function
• Total daily insulin requirements of more than 1.4 U/kg
• Cardiac problems
• Uncontrolled hypertension
• Known or suspected allergy to trial product or related products
• Current hypoglycaemic unawareness as judged by the investigator
• Known or suspect abuse of alcohol or narcotics
• Women breastfeeding or having the intention of becoming pregnant, or if judged not to be using adequate contraceptive measures (adequate measures are intrauterine device (IUD), oral contraception and barrier methods)
• Any condition that the Investigator and/or Sponsor feels would interfere with trial participation or evaluation of results