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
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
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
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
NCT ID
NCT00941161
First Posted
July 15, 2009
Last Updated
May 17, 2010
Sponsor
Laboratorios Silanes S.A. de C.V.
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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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.
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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.
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PubMed Identifier
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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.
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PubMed Identifier
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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.
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PubMed Identifier
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Citation
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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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