Overview

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

Status:
Completed
Trial end date:
2006-01-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Insulin
Insulin Aspart
Insulin degludec, insulin aspart drug combination
Insulin Glargine
Insulin, Globin Zinc
Insulin, Long-Acting
Criteria
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