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 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT03254368
Eligibility Criteria:
Inclusion Criteria:
Subjects must meet the following criteria to participate in this study:
* Be between the ages of 18 and 70 years, inclusive.
* Overweight or obese with a body mass index of at least 27 kg/m².
* Have type 2 diabetes with HbA1c between 7% and 11%.
* For subjects taking approved antidiabetes medications, the doses must be stable as determined by the study doctor.
* For subjects who have had weight-loss surgery (example: gastric banding), the procedure must have occurred at least 1 year ago, and be verified with documentation or by a health professional associated with the surgery.
Exclusion Criteria:
Subjects cannot participate in this research study if they meet any of the following:
* Have taken another study drug or study device within the past 6 months.
* Are taking certain prescribed medications including narcotics or opiates.
* Consistent recent use of insulin.
* Have had recent major surgery or prolonged bed rest, or planning or likely to undergo any surgery during the research study.
* Have a history of bleeding disorders or risk factors for excessive blood clotting.
* Have difficulty giving blood.
* Have a history of drug and/or alcohol abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03254368
Study Brief:
Protocol Section:
NCT03254368