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:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
NCT ID:
NCT03760068
Eligibility Criteria:
Inclusion criteria
1. Written and signed informed consent.
2. Clinical diagnosis of type 1 diabetes mellitus for at least 6 months prior to screening.
3. Subject is able and willing to comply with the requirements of the study protocol.
Exclusion Criteria
1. History or presence of a medical condition or disease that in the Investigator's opinion would place the subject at an unacceptable risk from study participation.
2. History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the study, OR history of significant allergic drug reactions.
3. Any clinically significant abnormality in electrocardiogram or safety laboratory tests.
4. Any elective surgery requiring hospitalization planned during the study period.
5. History of a significant medical condition, such as unstable angina, myocardial infarction, stroke or transient ischemic attack in the 6 months before screening.
6. Subjects with major depressive illness in the last 3 years.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03760068
Study Brief:
Protocol Section:
NCT03760068