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

• ClinicalTrials.gov Identifier: NCT00941161
• Recruitment Status: Completed
• First Posted: July 17, 2009
• Last Update Posted: May 18, 2010
• Sponsor: Laboratorios Silanes S.A. de C.V.
• Information provided by: Laboratorios Silanes S.A. de C.V.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Drug: metformin/glimepiride combination; Drug: metformin; Drug: glimepiride	Phase 4

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)

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: February 2009
• Actual Primary Completion Date: May 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: combination; long acting Metformin/Glimepiride	Drug: metformin/glimepiride combination; long acting metformin/glimepiride 1g/2mg
Active Comparator: metformin; metformin hydrocloride	Drug: metformin; long acting metformin 1g once a day with fasting glucose 130-199mg/dL or long actin metformin 1g twice a day (before dinner and before breakfast) with fasting glucose 200-270mg/dL
Active Comparator: glimepiride; glimepiride	Drug: glimepiride; glimepiride 2mg once a day with fasting glucose 130-199mg/dL, or glimepiride 2mg twice a day (before dinner and before breakfast) with fasting glucose 200-270mg/dL

Outcome Measures

Primary Outcome Measures :

1. fasting glucose, HbA1c [ Time Frame: three months ]

Secondary Outcome Measures :

1. total cholesterol, C-LDL, C-HDL, triglycerides, VLDL, insulin [ Time Frame: three months ]

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Mexico

Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara

Guadalajara, Jalisco, Mexico

Sponsors and Collaborators

Laboratorios Silanes S.A. de C.V.

Investigators

• Study Director: Jorge Gonzalez, M.D., Master; Laboratorios Silanes S.A. de C.V.
• Study Chair: Manuel Gonzalez, Ph.D.; University of Guadalajara
• Principal Investigator: Esperanza Martínez, Ph.D.; University of Guadalajara

More Information

Publications:

International Diabetes Federation / International Association for the Study of Obesity. Diabetes and Obesity 11-21, 2004

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. 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.

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. Erratum in: Diabetologia. 2006 Nov;49(11):2816-8.

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.

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.

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, Turner RC. Metformin. N Engl J Med. 1996 Feb 29;334(9):574-9. Review.

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.

• Responsible Party: Jorge Gonzalez Canudas, M.D., Laboratorios Silanes, S.A. de C.V.
• ClinicalTrials.gov Identifier: NCT00941161
• Other Study ID Numbers: DMGlime-04
• First Posted: July 17, 2009
• Last Update Posted: May 18, 2010
• Last Verified: May 2010

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Metformin; Glimepiride; Hypoglycemic Agents; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Immunosuppressive Agents; Immunologic Factors