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 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
NCT ID:
NCT01649466
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of type 2 diabetes mellitus.
* Contraindicated or intolerant to take metformin.
* HbA1c of ≥ 7.0% and ≤ 8.5%
* Current sulfonylurea (glimepiride) monotherapy and judged by the investigator to be inadequately controlled
* Other protocol-defined inclusion/exclusion criteria may apply
Exclusion Criteria:
* Patients who are taking any other anti-diabetes drug (oral or injection) other than an SU component in the preceding 12 weeks.
* Acute metabolic conditions such a ketoacidosis, lactic acidosis or hyperosmolar state within the past 6 month
* Patients taking sulfonylurea for longer than 5 years
* History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
* pregnancy
* Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01649466
Study Brief:
Protocol Section:
NCT01649466