How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics (MEXELIN)

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