NCT00941161

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-05-01
• First posted: 2009-07-17
• Last updated: 2010-05-18

Locations

1 site across 1 country: Mexico