NCT00361907 - 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)

Ellis G, Adatia I, Yazdanpanah M, Makela SK
Nitrite and nitrate analyses: a clinical biochemistry perspective. Clin Biochem. 1998 Jun;31(4):195-220. Review.
Hanke CJ, Drewett JG, Myers CR, Campbell WB
Nitric oxide inhibits aldosterone synthesis by a guanylyl cyclase-independent effect. Endocrinology. 1998 Oct;139(10):4053-60.
Mather KJ, Lteif A, Steinberg HO, Baron AD
Interactions between endothelin and nitric oxide in the regulation of vascular tone in obesity and diabetes. Diabetes. 2004 Aug;53(8):2060-6.

Effect of Pulsatile IV Insulin Delivery on Circulating Risk Markers of Vascular and Metabolic Complications in Pts With Diabetes

Clinical trial NCT00361907 - References