This protocol examines the comparative efficacy and metabolic effects of two novel anti-hyperglycemic agents in patients with Type II diabetes mellitus. Patients are screened and randomized to 3 months of monotherapy with either Troglitazone, a thiazolidinedione, or Metformin, a biguanide. At baseline, various metabolic testing is performed, including an 8 hour meal tolerance test and a hyperinsulinemic/euglycemic clamp in order to fully assess the subjects for pancreatic insulin secretory function, hepatic glucose production, and peripheral glucose disposal (as a measure of insulin sensitivity). These tests are repeated at 3 months. Subsequently, the patients are placed on combination therapy with both drugs for an additional 3 months. Testing is then repeated at 6 months. Our data thus far shows that both drugs are equally efficacious as monotherapy, with improvement noted in various parameters of glucose control as well as in peripheral glucose disposal. Troglitazone may have stronger peripheral effects, but the results are not yet significant statistically. Combination therapy is well-tolerated and results in further improvement in glucose control.
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