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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT00231660
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Type 2 diabetes and receiving metformin monotherapy for at least the previous 4 months and on a stable daily dose for at least 2 months prior to enrollment
* Metformin total daily dose not to exceed 2.1 grams/day
* Body Mass Index \>= 27 and \< 50
* HbA1c \< 11%
* Fasting plasma glucose \>= 126 and \< 240
* Stable weight
* Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, or practicing an acceptable method of contraception (requires negative pregnancy test)
Exclusion Criteria:
* Known contraindication, or hypersensitivity to topiramate
* Use of other antidiabetic medications within the last 4 months
* Excessive weight loss
* Diagnosis of type 1 diabetes
* History of severe or recurrent hypoglycemic episodes
* Severe pulmonary disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00231660
Study Brief:
Protocol Section:
NCT00231660