drugset / Trial / NCT00940472
Study on DMMET-01 Versus Metformin on Improvement of Metabolic Control in Naive Type 2 Diabetes Patients
RandomizedParallel-groupDouble-blindTreatment
Summary
The aim of this clinical trial is to compare the efficacy of DMMET-01 versus metformin hydrocloride on metabolic control in mexican type 2 diabetes patients without prior pharmacological treatment.
Timeline
- Start
- 2009-03
- Primary completion
- 2009-12
- Completion
- —
Publications
- Background 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. doi: 10.2337/diacare.27.5.1047.
- Background Aguilar-Salinas CA, Velazquez Monroy O, Gomez-Perez FJ, Gonzalez Chavez 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 Mexico: Results from a large population-based nationwide survey. Diabetes Care. 2003 Jul;26(7):2021-6. doi: 10.2337/diacare.26.7.2021.
- Background 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.
- Background Gonzalez-Ortiz M, Martinez-Abundis E, Kam-Ramos AM, Hernandez-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. doi: 10.1007/s10557-006-7805-x.
- Background Gonzalez-Ortiz M, Martinez-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.
- Background American Diabetes Association. Standards of medical care in diabetes--2007. Diabetes Care. 2007 Jan;30 Suppl 1:S4-S41. doi: 10.2337/dc07-S004. No abstract available.
- Background Jeyaseelan L, Rao PS. Methods of determining sample sizes in clinical trials. Indian Pediatr. 1989 Feb;26(2):115-21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Metformin | Small molecule | 850 mg | — |
| Subject | Metformin glycinate | Unknown | 1050.6 mg | — |