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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT03214367
Eligibility Criteria:
Inclusion Criteria:
* Have T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year.
* HbA1c of ≥7.0 and ≤9.5%.
* Use insulin lispro, insulin aspart, or insulin glulisine as prandial insulin.
* Use insulin glargine, insulin detemir, insulin degludec, or neutral protamine Hagedorn (NPH) insulin as basal insulin.
Exclusion Criteria:
* Have used other antihyperglycemic medications or therapies (inhaled, oral or injectable) within 90-days of screening.
* Have had more than 1 severe hypoglycemic episode within 6 months of screening.
* Have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months of screening.
* Have clinically significant gastrointestinal disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03214367
Study Brief:
Protocol Section:
NCT03214367