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 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT03703869
Eligibility Criteria:
Inclusion criteria :
* Signed patient informed consent;
* Type 2 diabetes mellitus;
* Treated with at least 1 oral antidiabetic drug (OAD) for at least 6 months;
* Hemoglobin A1c (HbA1c) \>7.0 % and ≤11% within 3 months of study baseline;
* Physicians' decision in accordance with the current local guidelines to add basal insulin glargine U300 to an existing OAD regimen
Exclusion criteria:
* Diabetes mellitus other than type 2;
* Contraindication to insulin glargine U300 according to local product labelling;
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
Study:
NCT03703869
Study Brief:
Protocol Section:
NCT03703869