NCT00940472 - 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)

Aguilar-Salinas CA, Velazquez Monroy O, Gómez-Pérez FJ, Gonzalez Chávez A, Esqueda AL, Molina Cuevas V, Rull-Rodrigo JA, Tapia Conyer R; Encuesta Nacional de Salud 2000 Group
Characteristics of patients with type 2 diabetes in México: Results from a large population-based nationwide survey. Diabetes Care. 2003 Jul;26(7):2021-6.
American Diabetes Association
Standards of medical care in diabetes--2007. Diabetes Care. 2007 Jan;30 Suppl 1:S4-S41.
González-Ortiz M, Martínez-Abundis E, Kam-Ramos AM, Hernández-Salazar E, Ramos-Zavala MG
Effect of ezetimibe on insulin sensitivity and lipid profile in obese and dyslipidaemic patients. Cardiovasc Drugs Ther. 2006 Apr;20(2):143-6.
González-Ortiz M, Martínez-Abundis E
Síndrome de resistencia a la insulina. En, Diabetes mellitus. Islas-Andrade S, Revilla-Monsalve C. McGrawHill-Interamericana. 3a. edición. México, 2005. ISBN p. 203-14.
González-Ortiz M, Martínez-Abundis E; Grupo para el Tratamiento de la Diabetes Mellitus con Combinaciones
[Efficacy and safety of glimepiride plus metformin in a single presentation, as combined therapy, in patients with type 2 diabetes mellitus and secondary failure to glibenclamide, as monotherapy]. Rev Invest Clin. 2004 May-Jun;56(3):327-33. Spanish.
Jeyaseelan L, Rao PS
Methods of determining sample sizes in clinical trials. Indian Pediatr. 1989 Feb;26(2):115-21.
Wild S, Roglic G, Green A, Sicree R, King H
Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53.

Randomized, Double-Blind, Efficacy and Safety, Controlled Study, Between DMMET-01 and Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetics Patients.

Details for clinical trial NCT00940472

Clinical trial NCT00940472 - References