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 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT00803920
Eligibility Criteria:
Inclusion Criteria:
* participant in Amylin Protocol 2993LAR-105
* at least 16 years of age
* type 2 diabetes being treated with stable regiment of metformin, SU, TZD, combination of metformin/SU, combination metformin/TZD, combination SU/TZD
* A1c 7.1 - 11
* fasting glucose less than 280 at screening
* BMI 25 - 45
* stable body weight 6 months prior to screening
* not pregnant and willing to practice birth control
* physical exam \& ECG not clinically significant
* lab values judged not to be clinically significant
* able to understand \& sign consent form
Exclusion Criteria:
* clinically significant medical condition as judged by investigator
* drug or alcohol abuse
* previous use of exenatide or any GLP-1 analog
* has used any investigational drug in the past 30 days prior to screening
* is currently using: alpha-glucosidase inhibitor, insulin, drugs that affect GI motility, use of systemic corticosteroids, use of medications with addictive potential, prescription or OTC weight-loss medications
* has donated blood within 60 days of screening, or is planning to donate during the study
* has had major surgery or blood transfusion within 2 months of screening
* has had a surgical procedure that may impact gastric emptying
* has any allergies or hypersensitivity to any component of study treatment
* is an immediate family member of personnel affiliated with the study at the investigative site
* is employed by Amylin, Lilly or Alkermes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00803920
Study Brief:
Protocol Section:
NCT00803920