NCT01529541

Efficacy and Safety of CWP-0403 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin Alone

A Multicenter, Randomized, Double-blind, Double Dummy, Active-controlled, Therapeutic Confirmatory Trial(Phase 3) to Evaluate the Efficacy and Safety of CWP-0403 Compared With Sitagliptin Added to Ongoing Metformin Therapy in Patients With Type 2 DM Insufficiently Controlled With Metformin Alone

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: JW Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is to evaluate the efficacy and safety of CWP-0403 compared to Sitagliptin by proving non-inferiority in patients with type 2 Diabetes Mellitus insufficiently controlled with metformin alone.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Anagliptin	Anagliptin 100mg, tablet, twice a day (BID)
DRUG	Sitagliptin	Sitagliptin 100mg, tablet, once a day (QD)

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-05-01
• Completion: 2013-10-01
• First posted: 2012-02-09
• Last updated: 2014-05-14

Locations

1 site across 1 country: South Korea