drugset / Trial / NCT00941161
Effect of Oral Combination Therapy in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus
RandomizedParallel-groupDouble-blindTreatment
Summary
The aim of the study is to determinate the effect of combined oral therapy of long acting metformin/glimepiride in a single dose in patients with type 2 diabetes mellitus and monotherapy failure.
Timeline
- Start
- 2009-02
- Primary completion
- 2010-05
- Completion
- —
Publications
- Background International Diabetes Federation / International Association for the Study of Obesity. Diabetes and Obesity 11-21, 2004
- Background Grundy SM, Pasternak R, Greenland P, Smith S Jr, Fuster V. AHA/ACC scientific statement: Assessment of cardiovascular risk by use of multiple-risk-factor assessment equations: a statement for healthcare professionals from the American Heart Association and the American College of Cardiology. J Am Coll Cardiol. 1999 Oct;34(4):1348-59. doi: 10.1016/s0735-1097(99)00387-3. No abstract available.
- Background Tseng KH. Standards of medical care in diabetes--2006: response to the American Diabetes Association. Diabetes Care. 2006 Nov;29(11):2563-4; author reply 2564-5. doi: 10.2337/dc06-0805. No abstract available.
- Background Cohen J, Colman P. Type 2 diabetes--the pharmacotherapy of glycaemic control and risk factor modification. Aust Fam Physician. 2006 Jun;35(6):380-4.
- Background Nathan DM, Buse JB, Davidson MB, Heine RJ, Holman RR, Sherwin R, Zinman B; Professional Practice Committee, American Diabetes Association; European Association for the Study of Diabetes. Management of hyperglycaemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy. A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia. 2006 Aug;49(8):1711-21. doi: 10.1007/s00125-006-0316-2. No abstract available.
- Background Riddle M. Combining sulfonylureas and other oral agents. Am J Med. 2000 Apr 17;108 Suppl 6a:15S-22S. doi: 10.1016/s0002-9343(00)00338-7.
- Background Bermudez-Pirela VJ, Cano C, Medina MT, Souki A, Lemus MA, Leal EM, Seyfi HA, Cano R, Ciscek A, Bermudez-Arias F, Contreras F, Israili ZH, Hernandez-Hernandez R, Valasco M. Metformin plus low-dose glimeperide significantly improves Homeostasis Model Assessment for insulin resistance (HOMA(IR)) and beta-cell function (HOMA(beta-cell)) without hyperinsulinemia in patients with type 2 diabetes mellitus. Am J Ther. 2007 Mar-Apr;14(2):194-202. doi: 10.1097/01.pap.0000249909.54047.0e.
- 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 Mandal U, Gowda V, Ghosh A, Selvan S, Solomon S, Pal TK. Formulation and optimization of sustained release matrix tablet of metformin HCl 500 mg using response surface methodology. Yakugaku Zasshi. 2007 Aug;127(8):1281-90. doi: 10.1248/yakushi.127.1281.
- Background Schwartz S, Fonseca V, Berner B, Cramer M, Chiang YK, Lewin A. Efficacy, tolerability, and safety of a novel once-daily extended-release metformin in patients with type 2 diabetes. Diabetes Care. 2006 Apr;29(4):759-64. doi: 10.2337/diacare.29.04.06.dc05-1967.
- Background Bailey CJ, Turner RC. Metformin. N Engl J Med. 1996 Feb 29;334(9):574-9. doi: 10.1056/NEJM199602293340906. No abstract available.
- Background McCall AL. Clinical review of glimepiride. Expert Opin Pharmacother. 2001 Apr;2(4):699-713. doi: 10.1517/14656566.2.4.699.
- Background Schneider J. An overview of the safety and tolerance of glimepiride. Horm Metab Res. 1996 Sep;28(9):413-8. doi: 10.1055/s-2007-979829.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glimepiride | Small molecule | 2 mg | Oral |
| Subject | Metformin | Small molecule | 1 g | Oral |