NCT00064714 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Bach JF, Chatenoud L
Tolerance to islet autoantigens in type 1 diabetes. Annu Rev Immunol. 2001;19:131-61. Review.
Lernmark A, Bärmeier H, Dube S, Hagopian W, Karlsen A, Wassmuth R
Autoimmunity of diabetes. Endocrinol Metab Clin North Am. 1991 Sep;20(3):589-617. Review.
Mathis D, Vence L, Benoist C
beta-Cell death during progression to diabetes. Nature. 2001 Dec 13;414(6865):792-8. Review.

Effect of AC 2993 (Synthetic Exendin-4) - Administered Alone or in Combination With Daclizumab - on Islet Function in Patients With Type I Diabetes

Clinical trial NCT00064714 - References