NCT01444248

Compare the Compliance of Patients Treated With Once-daily (od) or Twice-daily (Bid) Glimepiride and Metformin Fixed Combination Therapy

A Multi-center, Open, Randomized, Parallel-group Study to Compare the Compliance of Patients Treated With Once-daily (od) or Twice-daily (Bid) Glimepiride and Metformin Fixed Combination Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Handok Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study design of this trial is open-label, randomized, multi-center, parallel-group study.

Detailed description

The effectiveness of treatment of a disease depends mainly on two factors: the efficacy of the treatment and the compliance of the patient with this treatment. Polymedication is one of the predisposing factors to low compliance in type 2 DM. It can be expected that a simple regimen may improve compliance. Amaryl Mex phase III trial was not designed to compare the compliance of patients with different dosing regimens of oral antidiabetic drugs. However, it was found that patients' compliance in the morning was better than in the evening, suggesting that Amaryl Mex once daily regimen may improve compliance. Pill count is the gold standard for measuring compliance, but this method provides incomplete and unreliable results. Advanced electronic monitoring device obtains details of patients' behavior during the day and over long periods.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Glimepiride/ Metformin	4/1000mg once daily
DRUG	Glimepiride/ Metformin	4/1000mg bid

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-12-01
• Completion: 2012-05-01
• First posted: 2011-09-30
• Last updated: 2012-08-23

Locations

1 site across 1 country: South Korea