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

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: JW Pharmaceutical
• Treatments: Anagliptin; Metformin; Sitagliptin Phosphate

Criteria

Inclusion Criteria:

• Patients who had diagnosed with type 2 DM before 3 months

• Men and women between the age of ≥ 19 and ≤ 75 years

• FPG ≤ 270 mg/dL at screening visit

• Patients who consent to participate in this trial by written Informed Consent Form

Exclusion Criteria:

• Type 1 DM or secondary diabetes

• Subjects who are administrating oral anti-hyperglycemic drugs or have to take a medicine

• Body mass index < 20 kg/m2 or > 40.0kg/m2

• Subjects who are assessed to be inappropriate for this trial by investigator