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

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.
• •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.