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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
metformin/glimepiride combination
metformin
glimepiride
Sponsored by
Laboratorios Silanes S.A. de C.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

combination

metformin

glimepiride

Arm Description

long acting Metformin/Glimepiride

metformin hydrocloride

glimepiride

Outcomes

Primary Outcome Measures

fasting glucose, HbA1c

Secondary Outcome Measures

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

Full Information

First Posted
July 15, 2009
Last Updated
May 17, 2010
Sponsor
Laboratorios Silanes S.A. de C.V.
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1. Study Identification

Unique Protocol Identification Number
NCT00941161
Brief Title
Effect of Oral Combination Therapy in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus
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 Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Laboratorios Silanes S.A. de C.V.

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
combination
Arm Type
Experimental
Arm Description
long acting Metformin/Glimepiride
Arm Title
metformin
Arm Type
Active Comparator
Arm Description
metformin hydrocloride
Arm Title
glimepiride
Arm Type
Active Comparator
Arm Description
glimepiride
Intervention Type
Drug
Intervention Name(s)
metformin/glimepiride combination
Intervention Description
long acting metformin/glimepiride 1g/2mg
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
glimepiride
Intervention Description
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
Primary Outcome Measure Information:
Title
fasting glucose, HbA1c
Time Frame
three months
Secondary Outcome Measure Information:
Title
total cholesterol, C-LDL, C-HDL, triglycerides, VLDL, insulin
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Gonzalez, M.D., Master
Organizational Affiliation
Laboratorios Silanes S.A. de C.V.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Manuel Gonzalez, Ph.D.
Organizational Affiliation
University of Guadalajara
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Esperanza Martínez, Ph.D.
Organizational Affiliation
University of Guadalajara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
City
Guadalajara
State/Province
Jalisco
Country
Mexico

12. IPD Sharing Statement

Citations:
Citation
International Diabetes Federation / International Association for the Study of Obesity. Diabetes and Obesity 11-21, 2004
Results Reference
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PubMed Identifier
10520820
Citation
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.
Results Reference
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PubMed Identifier
17065711
Citation
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.
Results Reference
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PubMed Identifier
16751851
Citation
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.
Results Reference
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PubMed Identifier
16802130
Citation
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. Erratum In: Diabetologia. 2006 Nov;49(11):2816-8.
Results Reference
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PubMed Identifier
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Citation
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.
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PubMed Identifier
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Citation
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.
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
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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.
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Citation
Bailey CJ, Turner RC. Metformin. N Engl J Med. 1996 Feb 29;334(9):574-9. doi: 10.1056/NEJM199602293340906. No abstract available.
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Citation
McCall AL. Clinical review of glimepiride. Expert Opin Pharmacother. 2001 Apr;2(4):699-713. doi: 10.1517/14656566.2.4.699.
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Effect of Oral Combination Therapy in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus

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