Effect of Oral Combination Therapy in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus
Overview[ - collapse ][ - ]
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. |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: metformin/glimepiride combination Drug: metformin Drug: glimepiride |
Phase | Phase 4 |
Sponsor | Laboratorios Silanes S.A. de C.V. |
Responsible Party | Laboratorios Silanes S.A. de C.V. |
ClinicalTrials.gov Identifier | NCT00941161 |
First Received | July 15, 2009 |
Last Updated | May 17, 2010 |
Last verified | May 2010 |
Tracking Information[ + expand ][ + ]
First Received Date | July 15, 2009 |
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Last Updated Date | May 17, 2010 |
Start Date | February 2009 |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures | fasting glucose, HbA1c [Time Frame: three months] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures | total cholesterol, C-LDL, C-HDL, triglycerides, VLDL, insulin [Time Frame: three months] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
Brief Title | Effect of Oral Combination Therapy in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus |
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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 |
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) |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: metformin/glimepiride combination long acting metformin/glimepiride 1g/2mg 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 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 |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 28 |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | May 2010 |
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 |
Gender | Both |
Ages | 40 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Mexico |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00941161 |
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Other Study ID Numbers | DMGlime-04 |
Has Data Monitoring Committee | Yes |
Information Provided By | Laboratorios Silanes S.A. de C.V. |
Study Sponsor | Laboratorios Silanes S.A. de C.V. |
Collaborators | Not Provided |
Investigators | Study Director: Jorge Gonzalez, M.D., Master Laboratorios Silanes S.A. de C.V.Study Chair: Manuel Gonzalez, Ph.D. Universidad de GuadalajaraPrincipal Investigator: Esperanza Martínez, Ph.D. Universidad de Guadalajara |
Verification Date | May 2010 |
Locations[ + expand ][ + ]
Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara | Guadalajara, Jalisco, Mexico |
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