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

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: metformin/glimepiride combination
* Drug: metformin
* Drug: glimepiride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: combination<br>long acting Metformin/Glimepiride | Drug: metformin/glimepiride combination<br>* long acting metformin/glimepiride 1g/2mg<br>|
| Active Comparator: metformin<br>metformin hydrocloride | Drug: metformin<br>* 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<br>|
| Active Comparator: glimepiride<br>glimepiride | Drug: glimepiride<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting glucose, HbA1c |  | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total cholesterol, C-LDL, C-HDL, triglycerides, VLDL, insulin |  | three months |