NCT00888719

Therapeutic Exploratory Study of CWP-0403

A Prospective, Randomized, Double Blinded, Multicenter and Therapeutic Exploratory Study to Comparatively Assess Efficacy and Safety of CWP-0403 in Type 2 Diabetes Patients Who Are Insufficiently Controlled by Diet and Exercise.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: JW Pharmaceutical · Industry
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Objective of the trial is to assess dose-dependency, efficacy and safety and to estimate optimum dosage for confirmatory study of CWP-0403 50mg, 100mg given twice daily for 12 weeks to type 2 diabetes patients who are insufficiently controlled by diet and exercise in comparison to placebo.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	CWP-0403 100mg	100mg/tablet, Twice a day, 1 tablet at a time for 12 weeks
DRUG	placebo	Tablet not containing CWP-0403 and indistinguishable from CWP-0403 50mg, 100mg tablets. Twice a day, 1 tablet at a time for 12 weeks
DRUG	CWP-0403 50mg	50mg/tablet, Twice a day, 1 tablet at a time for 12 weeks

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-01-01
• Completion: 2010-04-01
• First posted: 2009-04-28
• Last updated: 2010-11-05

Locations

10 sites across 1 country: South Korea