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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT01557504
Eligibility Criteria:
Inclusion Criteria:
* Female participant of reproductive potential must not be pregnant and agrees to use (and/or have their partner use) two acceptable methods of birth control
* T2DM diagnosed by American Diabetes Association criteria
* No clinically significant abnormality on electrocardiogram
* No clinical or laboratory evidence to indicate a diagnosis of type 1 diabetes
* Nonsmoker
Exclusion Criteria:
* Mental or legal incapacitation
* Estimated creatinine clearance of 80 mL/min or lower
* History of stroke, chronic seizures, or major neurological disorder
* History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* History of neoplastic disease
* Unable to refrain from or anticipates the use of any medication (with the exception of metformin and thyroid hormone) from approximately 2 weeks before the first dose of study drug through the poststudy visit
* Consumes alcohol or consumes excessive amounts of coffee, tea, cola, or other caffeinated beverages
* Had surgery, donated or lost 1 unit of blood, or participated in another investigational study within the past 4 weeks
* History of multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
* Currently a regular user (including illicit drugs) or has a history of drug (including alcohol) abuse
* Lactose intolerant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
17 Years
Study:
NCT01557504
Study Brief:
Protocol Section:
NCT01557504