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

NCT00941161 | Completed Phase 4 DMC

• 1 other identifier: DMGlime-04
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• fasting glucose, HbA1c

  three months

Secondary Outcomes (1)

• total cholesterol, C-LDL, C-HDL, triglycerides, VLDL, insulin

  three months

Study Arms (3)

combination

EXPERIMENTAL

long acting Metformin/Glimepiride

Drug: metformin/glimepiride combination

metformin

ACTIVE COMPARATOR

metformin hydrocloride

Drug: metformin

glimepiride

ACTIVE COMPARATOR

glimepiride

Drug: glimepiride

Interventions

metformin/glimepiride combination DRUG

long acting metformin/glimepiride 1g/2mg

combination

metformin DRUG

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

metformin

glimepiride DRUG

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

glimepiride

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratorios Silanes S.A. de C.V.: lead

Study Sites (1)

Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara

Guadalajara, Jalisco, Mexico

Location

Related Publications (13)

• 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.

  PMID: 10520820 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.

  PMID: 17065711 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.

  PMID: 16751851 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.

  PMID: 16802130 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.

  PMID: 10764846 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.

  PMID: 17414590 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.

  PMID: 15612515 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.

  PMID: 17666882 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.

  PMID: 16567811 BACKGROUND

• Bailey CJ, Turner RC. Metformin. N Engl J Med. 1996 Feb 29;334(9):574-9. doi: 10.1056/NEJM199602293340906. No abstract available.

  PMID: 8569826 BACKGROUND

• McCall AL. Clinical review of glimepiride. Expert Opin Pharmacother. 2001 Apr;2(4):699-713. doi: 10.1517/14656566.2.4.699.

  PMID: 11336617 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.

  PMID: 8911975 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; glimepiride

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Jorge Gonzalez, M.D., Master

  Laboratorios Silanes S.A. de C.V.

  STUDY DIRECTOR

• Manuel Gonzalez, Ph.D.

  University of Guadalajara

  STUDY CHAIR

• Esperanza Martínez, Ph.D.

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 15, 2009
• First Posted: July 17, 2009
• Study Start: February 1, 2009
• Primary Completion: May 1, 2010
• Last Updated: May 18, 2010

Record last verified: 2010-05

Locations

ME (1)