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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Silanes S.A. de C.V.
• Treatments: Glimepiride; Metformin

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