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 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT02075567
Eligibility Criteria:
Inclusion Criteria:
* Subjects must give their signed and dated informed consent before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject
* Male subjects with T1DM with duration ≥12 month
* Age ≥ 18 to ≤ 35 years, both inclusive
* HbA1c ≤ 64 mmol/mol
* Fasting C-peptide ≤ 0.3 nmol/l
* Treatment with intensified insulin therapy or insulin pump therapy
* No diabetic long term complications
* No other physical and/or mental disease
Exclusion Criteria:
* Previous participation in this trial
* History of any illness or disease that, in the opinion of the Investigator might confound the results of the trial
* Use of drugs, which may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia
* Current addiction to alcohol or substances of abuse as determined by the investigator
* Known or suspected allergy to trial products or related products
* Any condition that the investigator feels would interfere with the trial participation or evaluation of data
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT02075567
Study Brief:
Protocol Section:
NCT02075567