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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: glimepiride; Drug: metformin/glimepiride combination; Drug: metformin

• Registration Number: NCT00941161
• Lead Sponsor: Laboratorios Silanes S.A. de C.V.

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 Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-07-15
• Study First Submitted QC: 2009-07-16
• Study First Posted: 2009-07-17
• Status Verified: 2010-05
• Primary Completion: 2010-05
• Last Update Submitted: 2010-05-17
• Last Update Posted: 2010-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
glimepiride	glimepiride	glimepiride
combination	metformin/glimepiride combination	long acting Metformin/Glimepiride
metformin	metformin	metformin hydrocloride

Primary Outcome Measures

Name	Time	Method
fasting glucose, HbA1c	three months

Secondary Outcome Measures

Name	Time	Method
total cholesterol, C-LDL, C-HDL, triglycerides, VLDL, insulin	three months

Trial Locations

Locations (1)

Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara; 🇲🇽 Guadalajara, Jalisco, Mexico