Comparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes
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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.
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
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
30 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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 %
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