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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo of Anagliptin; Drug: Anagliptin

• Registration Number: NCT01529528
• Lead Sponsor: JW Pharmaceutical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2012-02-06
• Study First Submitted QC: 2012-02-08
• Study First Posted: 2012-02-09
• Primary Completion: 2012-09
• Study Completion: 2012-11
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-02
• Last Update Posted: 2013-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo of CWP-0403 100mg	Placebo of Anagliptin	Placebo of CWP-0403 100mg
CWP-0403 200mg	Anagliptin	CWP-0403 200mg
CWP-0403 100mg	Anagliptin	CWP-0403 100mg

Primary Outcome Measures

Name	Time	Method
The Change in HbA1c from baseline to week24	0wk, 8wk, 16wk, 24wk

Secondary Outcome Measures

Name	Time	Method
change from baseline to week 24 in HOMA-β	owjm 24wk
The proportion of subjects achieving HbA1c<7% at week24	0wk, 8wk, 16wk, 24wk
The change from baseline to week 24: Fasting plasma glucose	0wk, 24wk
change from baseline to week 24 in Fasting serum pro-insulin	0 wk, 24wk
change from baseline to week 24 in Fasting serum insulin	0 wk, 24 wk
The proportion of subjects achieving HbA1c<6.5% at week24	0wk, 8wk, 16wk, 24wk
change in from baseline to week 24 fasting serum c-peptide	0wk, 24wk
change from baseline to week 24 in HOMA-IR	0wk, 24 wk

Trial Locations

Locations (1)

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of