A Study to Efficacy and Safety of CWP-0403 in Type 2 Diabetes Mellitus Patients

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is to evaluate the efficacy and safety of CWP-0403 at 100 mg or 200 mg twice daily compared with placebo in type 2 diabetic patients with inadequate glycemic control by diet therapy or combination of diet and exercise therapy.

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

Details

• Lead Sponsor: JW Pharmaceutical
• Treatments: Anagliptin

Criteria

Inclusion Criteria:

• Type 2 DM patients

• Subjects who couldn't control the blood glucose despite of a dietary and exercise therapy more than 6 weeks at screening visit

• FPG ≤ 270mg/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 insulin or need to insulin therapy

• History of oral anti-hyperglycemic drugs within 6 weeks before screening visit

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

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