NCT00501020 - 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)

Goldstein BJ, Cobitz AR, Hand LM, Chen H
Are the metabolic effects of rosiglitazone influenced by baseline glycaemic control? Curr Med Res Opin. 2003;19(3):192-9.
Rosenstock J, Goldstein BJ, Wooddell MJ, Strow LJ, Waterhouse BR, Cobitz AR Greater benefits of rosiglitazone added to submaximal dose of metformin compared to maximizing metformin dose in type 2 diabetes mellitus patients
Diabetes 2004; 53 (Suppl 2): A1
Weissman PW, Goldstein BJ, Campbell JC, Gould ER, Waterhouse BR, Strow LJ, Cobitz AR
Rosiglitazone plus metformin combination effects on CV risk markers suggest potential CV benefits in type 2 diabetes patients. Diabetes 2004;53(Suppl 2): A28 Oral presen

A 24-Week Randomized, Double-blind, Double-Dummy, Multicenter Study to Compare the Efficacy of AVANDIA When Added to Submaximal Doses of Metformin and to Compare the Tolerability of the Combination to Metformin Monotherapy When Administered to Subjects With Type 2 Diabetes Mellitus

Details for clinical trial NCT00501020

Clinical trial NCT00501020 - References