Effect of Oral Combination Therapy in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: metformin/glimepiride combination (Drug); metformin (Drug); glimepiride (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Laboratorios Silanes S.A. de C.V.

Official(s) and/or principal investigator(s):
Jorge Gonzalez, M.D., Master, Study Director, Affiliation: Laboratorios Silanes S.A. de C.V.
Manuel Gonzalez, Ph.D., Study Chair, Affiliation: Universidad de Guadalajara
Esperanza Martínez, Ph.D., Principal Investigator, Affiliation: Universidad de Guadalajara

Overall contact:
Esperanza Martinez, Ph.D., Phone: +52 (33) 3617-0060, Ext: 31494, Email: uiec@prodigy.net

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.

Official title: Effect of Oral Combination Therapy of Metformin Extended Release Over Glimepiride in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus With Failure of Monotherapy

Study design: Treatment, Randomized, Double Blind (Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: fasting glucose, HbA1c

Secondary outcome: total cholesterol, C-LDL, C-HDL, triglycerides, VLDL, insulin

Detailed description: A randomized double-blind clinical trial, to determine the effect of combined therapy of oral prolonged-release metformin/glimepiride in a single dosage form on fasting glucose and HbA1c. Patients will be included in this study are patients with diabetes mellitus and secondary failure to monotherapy. Will also assess the effect of combined therapy on the oral lipid profile (total cholesterol, LDL, HDL, VLDL, Triglycerides) and on the sensitivity and insulin secretion. We evaluate the clinical measurements, laboratory and safety during 3 months, through the allocation of subjects to three study groups (metformin, glimepiride and metformin extended release / glimepiride)

Minimum age: 40 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 40 to 65 years old

- Ability to communicate and to meet the requirements of the study

- Signed Written Informed Consent before to conducting any study

- Body Mass Index (BMI) = 25-40kg/m2

- Stable weight in the past three months (variability <5%)

- Meal plan and monotherapy with oral hypoglycaemic fails

- Fasting glucose = 130-270 mg/dL

- HbA1c > 7%

- isocaloric diet with a minimum of 250 grams of carbohydrates per day in the three

days prior to making the laboratory tests

Exclusion Criteria:

- Suspected or confirmed pregnancy

- Nursing

- Inability to secure the non-pregnant during the study duration

- Hypersensitivity to any of the drugs under study

- Treatment with oral hypoglycemic or insulin

- Consumption of substance with toxic effects on any organ system

- Liver failure, heart failure, kidney failure or thyroid disease

- Chronic intake of alcohol

- Periods of acute or chronic diarrhea or vomiting

- Consumption of antifungal azoles, MAO inhibitors, nifedipine,furosemide, amiloride,

digoxin, procainamide, quinidine, quinine, triamterene and vancomycin

Esperanza Martinez, Ph.D., Phone: +52 (33) 3617-0060, Ext: 31494, Email: uiec@prodigy.net

Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara, Guadalajara, Jalisco, Mexico; Recruiting
Jorge Gonzalez, M.D:, Master, Phone: +52 (55) 5488-3700, Ext: 3761, Email: JOGonzalez@silanes.com.mx
Jimena M Iglesias, M.D., Phone: +52 (55) 5488-3700, Ext: 3810, Email: jiglesias@silanes.com.mx
Manuel Gonzalez, Ph.D., Principal Investigator

Related publications:

Marre M. Reducing cardiovascular risk in diabetes. J Hypertens Suppl. 2007 Jun;25(1):S19-22. Review.

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. No abstract available.

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.

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. No abstract available.

Riddle M. Combining sulfonylureas and other oral agents. Am J Med. 2000 Apr 17;108 Suppl 6a:15S-22S. Review.

Bermúdez-Pirela VJ, Cano C, Medina MT, Souki A, Lemus MA, Leal EM, Seyfi HA, Cano R, Ciscek A, Bermúdez-Arias F, Contreras F, Israili ZH, Hernández-Hernández 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.

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.

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.

Bailey CJ, Path MRC, Turner RC. Metformin. N Engl J Med 334: 574-579, 1996

McCall AL. Clinical review of glimepiride. Expert Opin Pharmacother. 2001 Apr;2(4):699-713. Review.

Schneider J. An overview of the safety and tolerance of glimepiride. Horm Metab Res. 1996 Sep;28(9):413-8. Review.

Starting date: February 2009
Ending date: November 2009
Last updated: July 16, 2009