Investigation of the Impact of Different Application Volumes of Insulin Aspart in Subjects With Type 1 Diabetes

Inclusion criteria

• Informed consent obtained after being advised of the nature of the study
• Male or female aged 18-60 years (both inclusive)
• Type 1 diabetes treated with multiple daily insulin injection or continuous subcutaneous insulin infusion for 12 months
• Fasting C-peptide < 0.3nmol/L
• Body mass index 20.0-28.0 kg/m² (both inclusive)
• HbA1c < 10%

Exclusion criteria

• Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
• Skin pathology or condition prohibiting needle insertion/insulin administration as judged by the investigator
• History of bleeding disorder
• Current participation in another clinical study
• Significant acute or chronic illness that might interfere with subject safety or integrity of results as judged by the investigator
• Smoker (defined as >5 cigarettes/d)
• Lipodystrophy
• Current treatment with systemic (oral or i.v.) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, growth hormone, herbal products or non-routine vitamins. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months.
• Significant history of alcoholism or drug abuse or a positive result in urine drug/alcohol screen.

Study Day Exclusion Criteria:

• Strenuous exercise within the last 24 hours prior to dosing.
• Non-fasting (i.e. consumption of food or beverages, other than water, later than 22:00 hours the evening before the visit) except if slight intake of rapidly absorbable carbohydrates has been necessary in order to prevent hypoglycaemia.
• Injection of long-acting insulin (e.g. insulin glargine or insulin detemir) later than 12:00 hours (noon), 2 days before the dosing visit.
• Injection of NPH insulin or other intermediate-acting insulin products later than 12:00 hours (noon) on the day before the dosing visit.
• Injection of any short acting insulin (aspart, lispro, glulisine) or more than 6 IU of human insulin between 22:00 hours and 03:00 hours the night before the dosing visit.
• Injection of any insulin later than 03:00 hours the night before the dosing visit.
• Infusion of any insulin later than 03:00 hours the night before the dosing visit for subjects using continuous subcutaneous insulin infusion (CSII).
• Positive result of alcohol breath test.
• Any medical condition that, in the opinion of the Investigator, could interfere with insulin pharmacokinetics and/or glucose metabolism.