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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT00806520
Eligibility Criteria:
Inclusion Criteria:
* 18 years or older
* type 2 diabetes
* A1c 7.1 - 11
* BMI 25 - 45
* stable weight for 3 months before screening
* fasting glucose \< 280 at screening
* stable dose of metformin for at least 2 months before screening
* not being treated with or on a stable dose of hormone replacement therapy, oral contraceptives, anti-hypertensive agents, lipid lowering agents, thyroid replacement therapy, anti-depressants, drugs known to affect body weight
* male or female, non-lactating, non-pregnant and willing to use birth control
* lab values that are not clinically significant at screening
* physical exam and ECG that are not clinically significant at screening
* able to read, understand, and sign consent form
Exclusion Criteria:
* liver disease
* renal disease
* cardiovascular disease
* gastroparesis
* cancer within 5 years of screening
* macular edema
* chronic infections
* drug or alcohol abuse
* fasting triglycerides \> or = 600 at screening
* previous exposure to exenatide LAR
* has donated blood within 60 days of screening or is planning to donate during the study
* has had a major surgery or blood transfusion within 2 months before screening
* is currently being treated or is expecting to be treated with Byetta, Januvia, SU, TZD, GLP-1 analog, alpha-glucosidase inhibitor, meglitinide, nateglinide, symlin, insulin, systemic corticosteroids, lopid or rifampin
* has received an investigational drug within 1 month before screening
* has allergies or hypersensitivity to any component of the study drug
* has previously had an adverse event related to TZD or Januvia
* is an immediate family member of the study sight or directly affiliated
* is employed by Amylin, Lilly or Alkermes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00806520
Study Brief:
Protocol Section:
NCT00806520