Comparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes

An Open-label, Randomised, In-patient, Cross Over PK/PD Trial Investigating the Pharmackinectic and Pharmacodynamic Profiles Following Continuous Subcutaneous Infusion of Insulin Aspart or Injection of Insulin Glargine in Subjects With Type 2 Diabetes Mellitus

This trial is conducted in Europe. The objective of the study is to investigate the effect and safety of continously basal delivered insulin aspart given by a pump versus once daily injection of insulin glargine.

Inclusion Criteria:

• Subjects with type 2 diabetes for more than 2 years
• Subjects currently treated with unchanged insulin glargine dose (10 -100 units) for 2 weeks
• Subjects currently treated with unchanged dose(s) for at least 1 month on one or two Oral Anti-diabetic drugs
• BMI 25 - 40 kg/m2
• HbA1c < 9.5 %

Exclusion Criteria:

• Known or suspected allergy to trial product(s) or related products
• Previous randomisation in this trial
• Pregnancy, breast-feeding, intention of becoming pregnant or pre-menopausal women judged not to be using adequate contraceptive measures (Only sterilisation, intra uterine devices and contraceptive pills are considered adequate contraceptive methods)
• Mental incapacity, unwillingness or language barriers precluding adequate understanding and co-operation.
• Any other significant illness such as endocrine, cardiac, neurological, malignant or other pancreatic illness judged by Investigator
• Participation in other studies within the last three months