Status:
COMPLETED
Comparison of Insulin Glargine Against Insulin Aspart Infused Under the Skin in Patients With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-75 years
Phase:
PHASE1
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 insul...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00184613
Start Date
May 1 2005
End Date
January 1 2006
Last Update
October 17 2016
Active Locations (1)
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1
Novo Nordisk Investigational Site
Århus C, Denmark, 8000