Delivery Systems, Diabetes, Diabetes Mellitus, Type 2
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