Status:
COMPLETED
Comparison of Insulin Detemir Produced by the Current Process and the NN729 Process in Healthy Subjects
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to demonstrate bioequivalence between insulin detemir produced by the NN729 process and by the current process in healthy subjects.
Eligibility Criteria
Inclusion
- Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
- Body mass index (BMI) between 18.0 and 27.0 kg/m\^2, inclusive
- Non-smoker
- Fasting plasma glucose (FPG) maximum 6.0 mmol/L
Exclusion
- Known or suspected allergy to trial products or related products
- Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, sterilisation, the oral contraceptive pill (which should have been taken without difficulty for at least 3 months) or an approved hormonal implant)
- A history of alcohol or drug abuse
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01490099
Start Date
August 1 2006
End Date
November 1 2006
Last Update
February 8 2016
Active Locations (1)
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1
Manchester, United Kingdom, M15 6SH