NCT00336310

A Double-Blind, Randomized, Parallel, Comparative Study to Evaluate the Efficacy and Safety of an Antidiabetic Agent Repaglinide for the Treatment of Type 2 Diabetes Mellitus Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (planned)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether a new-brand of repaglinide is effective in the treatment of type 2 diabetes patients.

Detailed description

This study is designed to evaluate the efficacy and safety of a new-brand of repaglinide X® in comparison to Novonorm® for the treatment of type 2 diabetes mellitus patients. Mentally competent patients with age of 30 to 75 years old in Taiwan of either sex with type 2 diabetes mellitus will be included. All eligible subjects will be randomized into treatment groups in 1:1 ratio. The treatment will consist of either X® or Novonorm® tid before meal for 12 weeks of treatment. The primary endpoints include the net change of HbA!c, fasting plasma glucose(FPG)and postprandial plasma glucose(PPG)at the end of 12th week evaluation compared to the baseline visit. Also, safety profiles including adverse event (such as hypoglycemia) incidences, blood pressure, liver, kidney function test will be monitored.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Repaglinide

Timeline

• Start date: 2006-07-01
• First posted: 2006-06-13
• Last updated: 2006-06-13

Locations

2 sites across 1 country: Taiwan