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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT00231634
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Type 2 Diabetes, receiving only second generation sulfonylurea therapy (may include: glipizide, gliclazide, glimepiride, glibenclamide/glyburide, and gliquadone) for at least 4 months and on stable dose for at least 2 months
* Body Mass Index \>= 27 and \< 50
* HbA1c \< 11% at enrollment
* Diagnosed hypertension or hyperlipidemia must be controlled
* Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing an acceptable method of contraception (requires negative pregnancy test)
Exclusion Criteria:
* Known contraindication or hypersensitivity to topiramate or sulfonylurea therapy
* Pregnancy or women who are nursing or plan to become pregnant during the study
* Diagnosed with Type 1 diabetes
* History of severe or recurrent hypoglycemic episodes
* Treatment with any antidiabetic agent other than sulfonylurea
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00231634
Study Brief:
Protocol Section:
NCT00231634