Status:
COMPLETED
Investigation of Pharmacodynamic Characteristics of Explorative Formulation of Insulin Degludec in Male Subjects With Type 1 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
MALE
18-69 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) of insulin degludec (insulin 454), an explorative formu...
Eligibility Criteria
Inclusion
- Male and are considered to be generally healthy, except for the underlying diabetes mellitus, based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
- Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months
- Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive)
- Glycosylated haemoglobin A1c (HbA1c) below or equal to 10.0 % based on central laboratory results
Exclusion
- History of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator
- Participation in any other trials involving investigational products within 3 months preceding the start of dosing
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01865318
Start Date
September 1 2006
End Date
January 1 2007
Last Update
October 22 2015
Active Locations (1)
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1
Neuss, Germany, 41460