Status:
COMPLETED
Bioequivalence Between Two Explorative Insulin Degludec Formulations and Between Two Explorative IDegAsp Formulations in Healthy Subjects
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This trial is conducted i Europe. The aim of this trial is to test for bioequivalence between two explorative formulations of insulin degludec (insulin 454) and between two explorative insulin deglude...
Eligibility Criteria
Inclusion
- Informed consent obtained before any trial-related activities. Trial related activities are any procedure that would not have been performed during the normal management of the subject
- 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)
- Fasting plasma glucose below or equal to 6 mmol/L
- Sexually active and non-sterilised participants must be informed that they and their partner must use a safe method of contraception during sexual intercourse (risk of pregnancy must be lower than 1%), e.g. implants, injections, combined oral contraceptives or hormonal intrauterinedevice or be willing to refrain from having sexual intercourse from the beginning of the study until up to three months after the conclusion of the study. This serves to exclude the possibilityof a pregnancy through sperm that could have been damaged by the study medication
Exclusion
- A history of any illness that, in the opinion of the investigator, might confound the results of the trial or pose risk in administering the trial product to the subject
- Known or suspected allergy to trial products or related products
- Subject who has participated in any other trials involving investigational products within the last 3 months prior to first dosing
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01868581
Start Date
May 1 2008
End Date
August 1 2008
Last Update
October 26 2015
Active Locations (1)
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1
Neuss, Germany, 41460