Status:
COMPLETED
Effect of Oral Combination Therapy in a Single Dosage Form in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Laboratorios Silanes S.A. de C.V.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
40-65 years
Phase:
PHASE4
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 wil...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00941161
Start Date
February 1 2009
Last Update
May 18 2010
Active Locations (1)
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1
Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, Mexico