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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT06062069
Eligibility Criteria:
Inclusion Criteria:
* Male or female, 18 years of age or older at the time of signing informed consent
* Have a documented clinical diagnosis of T1DM greater than or equal to 1 year before the Screening Visit
* Body mass index greater than or equal to27.0 kg/m2
* Hemoglobin A1c (HbA1c) level between 7.0% and 10.0%, inclusive, at the Screening Visit
Exclusion Criteria:
* Diagnosis of Type 2 diabetes mellitus (T2DM) or any other types of diabetes, except T1DM
* Experienced diabetic ketoacidosis (DKA) within 3 months prior to the Screening Visit
* Experienced severe hypoglycemia (Level 3 as defined in the ADA Standards of Medical Care in Diabetes (ADA 2022) within 3 months prior to the Screening Visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06062069
Study Brief:
Protocol Section:
NCT06062069