This protocol is designed to assess the effect of self-administered pramlintide on glucose control in patients with Type I diabetes. The primary efficacy parameter will be changes in glycated hemoglobin after 26 weeks of pramlintide or placebo therapy. Patients will be on a single-blind 28 day placebo lead-in. Patients will then be randomized and maintained on a specific dose regimen of pramlintide or placebo for the entire treatment period. We will be assessing changes in insulin regimens during this study. A reduction in insulin dose may be beneficial and has the potential to result in metabolic changes independent of the changes in postprandial glucose. Reducing insulin levels may be of benefit to a patient's lipid status and blood pressure as well, and because insulin stimulates appetite and increases fat stores, it is also useful to measure weight in this study. These too will be monitored.
Showing the most recent 10 out of 565 publications