Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Oregon Health and Science University
With
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Age
30–70
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
