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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT01865305
Eligibility Criteria:
Inclusion Criteria:
* The subject will be a male volunteer, who is considered to be generally healthy, except for underlying diabetes mellitus and concomitant medical complications (e.g. hypertension) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
* Glycosylated haemoglobin A1c (HbA1c) below or equal to 10 % based on central laboratory results
* ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 1 DIABETES:
* 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)
* ADDITIONAL INCLUSION CRITERA FOR SUBJECTS WITH TYPE 2 DIABETES:
* Diagnosed with type 2 diabetes mellitus for at least 12 months
* Treated with insulin for the last 3 months prior to screening.
* Body Mass Index (BMI) between 22.0 and 35.0 kg/m\^2 (both inclusive)
Exclusion Criteria:
* A subject with a 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
* A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT01865305
Study Brief:
Protocol Section:
NCT01865305