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 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT00667732
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients with type 2 diabetes
* Taking metformin at least 1000 mg daily plus a secretagogue, an alpha glucosidase inhibitor, a thiazolidinedione, or a single injection of any kind of insulin up to 0.4 units/kg daily for \> 3 months
* Age range 30 to 70 years
* Body mass index 25-45 kg/m2
* HbA1c 7.0 to 10.0% (or 7.0 to 8.5% if the second antihyperglycemic agent is insulin)
* Less than 50% of randomized participants will have used insulin previously
Exclusion Criteria:
* Use of more than two antihyperglycemic agents within the last 3 months
* Use of more than one daily injection of any kind of insulin in the last 3 months
* Positive anti-GAD antibody (test required in screening)
* Fasting C-peptide \<0.5 ng/mL (test required in screening)
* Pregnancy (test required in screening if able to conceive) or lactation
* Excessive use of alcohol or evidence of other form of drug dependency
* Unwillingness or inability to grant informed consent
* Unwillingness or inability to perform self-monitoring of blood glucose
* Unwillingness or inability to inject insulin and/or inject exenatide
* Serum creatinine \>1.3 mg/dL in women or 1.4 in men
* Retinopathy which has required photocoagulation for treatment
* Major active systemic illness (e.g. neoplastic disorder, symptomatic ischemic heart disease, congestive heart failure) that might interfere with performing the study protocol
* Clinically significant gastrointestinal disorder including prior gastric or intestinal surgery for weight-control
* Ongoing use of any drug (e.g. narcotic analgesic, tricyclic antidepressant) that might alter gastric emptying
* Use prednisone or other systemic glucocorticoid drug in the last 3 months
* Use of any drug for weight-control (e.g. sibutramine, phentermine, orlistat) in the last 3 months
* Use of any unproven investigational drug within the last 3 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT00667732
Study Brief:
Protocol Section:
NCT00667732