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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT00229658
Eligibility Criteria:
Inclusion Criteria:
* The following inclusion criteria are consistent with information in the SYMLIN package insert and apply to insulin using patients with type 2 or type 1 diabetes who:
* Have failed to achieve the desired or optimal level of glycemic control despite utilizing appropriate, individualized insulin regimens
* Have A1C \<=9.0% within 3 months of study enrollment
* Are receiving ongoing diabetes care under the guidance of a Health Care Provider (HCP) trained in the use of SYMLIN
Exclusion Criteria:
* The following exclusion criteria are consistent with the SYMLIN package insert and specifically exclude patients who:
* Are poorly compliant with their current insulin regimen, as defined by their HCP
* Are poorly compliant with prescribed blood glucose self monitoring, as defined by their HCP
* Have experienced recurrent patient-ascertained severe hypoglycemia requiring assistance during the past 6 months
* Have hypoglycemia unawareness
* Have a confirmed diagnosis of gastroparesis
* Require the use of drugs that stimulate gastrointestinal motility
* Are female and pregnant or lactating and for whom the HCP determines the potential benefit does not justify the potential risk to the fetus or infant
* Have been treated with SYMLIN within 3 months prior to study start
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00229658
Study Brief:
Protocol Section:
NCT00229658