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 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT01537120
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of type 2 diabetes mellitus on a clinical regimen that is metformin alone, up to a maximum of 3 gram per day, on a background of lifestyle measures, and has a Hemoglobin A1C at screening of \> 7%.
* If on antihyperglycemic therapy with both metformin and sulfonylurea with a Screening Visit/Visit 1 Hemoglobin A1C of \>= 6.5% and =\< 7.5%, should then discontinue sulfonylurea usage and undergo washout of sulfonylurea.
Exclusion Criteria:
* History of either stroke, chronic seizures or major neurological disorder within the last 6 months.
* Untreated hypertension with a blood pressure of \> 160/95 mmHg.
* History of neoplastic disease within the past 5 years.
* History of hypersensitivity to vildagliptin or other DPP4 inhibitors.
* Had major surgery, or donated or lost 1 unit (500 mL) of blood, or participated in another investigational study within 4 weeks prior to screen.
* Used any illicit drug or abusively used alcohol within the past 3 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT01537120
Study Brief:
Protocol Section:
NCT01537120