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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT01257451
Eligibility Criteria:
Inclusion Criteria:
* age: ≥ 70 years inclusive at Visit 1.
* patients with a confirmed diagnosis of T2DM
* HbA1c of ≥ 7% and ≤10.0% by central laboratory at Visit 1 and assessed by the investigator to be inadequately controlled
* body mass index (BMI) in the range of 19-45kg/m2
Exclusion Criteria:
* FPG ≥ 270 mg/dL (≥ 15.0 mmol/L)
* previous or current participation in any vildagliptin clinical study.
* history of hypersensitivity to DPP-4 inhibitors.
* concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
* donation of blood or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT01257451
Study Brief:
Protocol Section:
NCT01257451