Diabetes, Diabetes Mellitus, Type 2, Delivery Systems
Conditions
Brief 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.
Interventions
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variation in morning FPG | Collected in hospital on the last 5 days of 7 days hospitalization, and on the morning of discharge |
Secondary
| Measure | Time frame |
|---|---|
| Variation of plasma endogenous insulin and insulin aspart/glargine collected in hospital on the last 5 days and the morning on discharged | — |
| Variation of pre-dinner plasma glucose collected in hospital on the last 3 days | — |
Countries
Denmark
Outcome results
None listed