TrialWatch
Below we highlight several currently enrolling clinical trials in diabetes. The trials are phase 2 or 3 studies, which generally means that the products they are testing have already met safety requirements for use in humans. These trials tend to seek large numbers of people in order to evaluate a treatment for approval by the FDA, the federal agency that approves drugs and devices in the US. The benefit of enrolling in a clinical trial is easy access to new treatments, as well as the potential to contribute to all patients by helping test new treatments. Click the links provided to find out more about these trials and, if you're interested, whether you can enroll.
Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes
This phase 3 study compares Minimed's sensor-augmented pump with the regular 715 model pump. TYPE 1.
Safety and Efficacy of Exenatide as Monotherapy
This phase 3 study will evaluate Byetta in people who are using no other diabetes drugs. See last issue's Learning Curve for more on what Byetta does and how it works! We believe strongly in earlier and more aggressive therapy and are excited to see this drug tested in those who haven't yet taken other drugs, presumably early in the course of disease. TYPE 2.
Effect of Liraglutide on Blood Glucose Control in Subjects with Type 2 Diabetes (LEAD-4)
This phase 3 study will evaluate liraglutide in people already taking metformin or TZDs (Avandia or Actos). There are a number of liraglutide LEAD trials — if interested, do a search at http://clinicaltrials.gov. Liraglutide is a GLP-1 analog like Byetta. TYPE 2.
Islet Cell Transplantation Alone in Patients With Type 1 Diabetes Mellitus: Steroid-Free Immunosuppression
This phase 2 study will assess the long-term safety and function of islet cell transplants. Transplants will likely be reserved for those with very specific entry requirements - if you think you might be interested, we encourage you to read the background information. TYPE 1.