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

Sponsor:	Laboratorios Silanes S.A. de C.V.
Information provided by:	Laboratorios Silanes S.A. de C.V.
ClinicalTrials.gov Identifier:	NCT00941161

Purpose

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	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: metformin/glimepiride combination Drug: metformin Drug: glimepiride	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Glimepiride Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Laboratorios Silanes S.A. de C.V.:

Primary Outcome Measures:

fasting glucose, HbA1c [ Time Frame: three months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

total cholesterol, C-LDL, C-HDL, triglycerides, VLDL, insulin [ Time Frame: three months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	28
Study Start Date:	February 2009
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
combination: Experimental long acting Metformin/Glimepiride	Drug: metformin/glimepiride combination long acting metformin/glimepiride 1g/2mg
metformin: Active Comparator 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
glimepiride: Active Comparator 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

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)

Eligibility

Ages Eligible for Study:	40 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00941161

Contacts

Contact: Esperanza Martinez, Ph.D.	+52 (33) 3617-0060 ext 31494	uiec@prodigy.net
Contact: Guadalupe Ramos, M.D.	+52 (33) 3617-0060 ext 31464	ramos.zavala.mg@gmail.com

Locations

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

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.	Universidad de Guadalajara
Principal Investigator:	Esperanza Martínez, Ph.D.	Universidad de Guadalajara

More Information

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.

Responsible Party:	Laboratorios Silanes, S.A. de C.V. ( Jorge Gonzalez Canudas, M.D. )
Study ID Numbers:	DMGlime-04
Study First Received:	July 15, 2009
Last Updated:	July 16, 2009
ClinicalTrials.gov Identifier:	NCT00941161 History of Changes
Health Authority:	Mexico: Federal Commission for Protection Against Health Risks

Additional relevant MeSH terms:

Metabolic Diseases
Immunologic Factors
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Immunosuppressive Agents

Pharmacologic Actions
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010