Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT01865318
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT01865318
Study Brief:
Protocol Section:
NCT01865318