NCT00124553 - 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)

Mann JI, De Leeuw I, Hermansen K, Karamanos B, Karlström B, Katsilambros N, Riccardi G, Rivellese AA, Rizkalla S, Slama G, Toeller M, Uusitupa M, Vessby B; Diabetes and Nutrition Study Group (DNSG) of the European Association
Evidence-based nutritional approaches to the treatment and prevention of diabetes mellitus. Nutr Metab Cardiovasc Dis. 2004 Dec;14(6):373-94.
New Zealand Guidelines Group
Assessment and Management of Cardiovascular Risk. December, 2003. Wellington, NZ. http://www.nzgg.org.nz. ISBN (print) 0-476-00091-2
New Zealand Guidelines Group
Management of Type 2 Diabetes. Wellington, NZ. December, 2003. http://www.nzgg.org.nz. ISBN (print): 0-476-00092-0

The Potential for Diet Modification to Improve Glycaemic Control and Cardiovascular Risk Factors Over and Above Drug Therapy in Type 2 Diabetes at High Risk of Cardiovascular Disease

Details for clinical trial NCT00124553

Clinical trial NCT00124553 - References