Comparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes
Phase 1
Completed
- Conditions
- DiabetesDelivery SystemsDiabetes Mellitus, Type 2
- Registration Number
- NCT00184613
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Variation in morning FPG Collected in hospital on the last 5 days of 7 days hospitalization, and on the morning of discharge
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇰Århus C, Denmark