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 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT03603704
Eligibility Criteria:
Inclusion Criteria:
* Have T2DM diagnosed at least 1 year ago
* Have hemoglobin A1c (HbA1c) ≥7.0% and ≤10.0% with fasting plasma glucose (FPG) ≥126 milligrams per deciliter (mg/dL) or HbA1c ≥6.5% and \<7.0% with FPG ≥144 mg/dL at screening
* Have body weight ≥54 kilograms and a body mass index \>18.5 and ≤40.0 kilograms per square meter at screening
Exclusion Criteria:
* Have received a total daily dose of insulin \>1.2 units per kilogram at screening
* Have taken any glucose-lowering medications, other than basal insulin, metformin and dipeptidyl peptidase-IV inhibitor, in the past 3 months before screening
* Have a history of multiple and/or severe allergies to drugs or foods, or a history of severe anaphylactic reaction
* Have a history of heart block or a repeated demonstration of abnormality in the 12-lead electrocardiogram at screening, which in the opinion of the investigator, increases the risks associated with participating in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT03603704
Study Brief:
Protocol Section:
NCT03603704