Effect of Oral Combination Therapy in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT00941161 |
Recruitment Status :
Completed
First Posted : July 17, 2009
Last Update Posted : May 18, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Mellitus | Drug: metformin/glimepiride combination Drug: metformin Drug: glimepiride | Phase 4 |
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 |

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 |
- fasting glucose, HbA1c [ Time Frame: three months ]
- total cholesterol, C-LDL, C-HDL, triglycerides, VLDL, insulin [ Time Frame: three months ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941161
Mexico | |
Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara | |
Guadalajara, Jalisco, Mexico |
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 |
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 Key Record Dates |
Last Update Posted: | May 18, 2010 |
Last Verified: | May 2010 |
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 |