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 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT00579150
Eligibility Criteria:
Inclusion Criteria:
The subjects must meet the following eligibility criteria for participation in the registry:
* Is pregnant and at least 18 years of age at the time of enrollment
* Had a diagnosis of type 2 diabetes prior to pregnancy
* Does not know the pregnancy outcome at the time of enrollment
* Has no knowledge of any existing structural or chromosomal defects detected on a prenatal test prior to enrollment
* Had been exposed to an immediate release formulation of exenatide (e.g. BYETTA®) or a non-insulin antidiabetic medication other than exenatide on or after the first day of the last menstrual period (insulin use will be allowed for both groups). OR participant has been exposed to an extended release formulation of exenatide (e.g. BYDUREON®) within 8 weeks of the first day of the last menstrual period
* Is willing and able to provide informed consent and an authorization for the pregnancy registry to contact the obstetric HCP, diabetes HCP, and the infant's pediatric HCP (and complete contact information for these practitioners, if different, and if available)
* Is able to understand spoken English or Spanish
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00579150
Study Brief:
Protocol Section:
NCT00579150