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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double Blind, Placebo Controlled, Therapeutic Confirmatory Trial(Phase 3) to Evaluate Efficacy and Safety of CWP-0403 in Type 2 DM Patients

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Anagliptin
* Drug: Anagliptin
* Drug: Placebo of Anagliptin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo of CWP-0403 100mg<br>Placebo of CWP-0403 100mg | Drug: Placebo of Anagliptin<br>* Placebo of Anagliptin 100mg, tablet, BID<br>|
| Experimental: CWP-0403 200mg<br>CWP-0403 200mg | Drug: Anagliptin<br>* Anagliptin 100mg, tablet, BID<br>|
| Experimental: CWP-0403 100mg<br>CWP-0403 100mg | Drug: Anagliptin<br>* Anagliptin 100mg, tablet, BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change in HbA1c from baseline to week24 |  | 0wk, 8wk, 16wk, 24wk | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects achieving HbA1c<6.5% at week24 |  | 0wk, 8wk, 16wk, 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 insulin |  | 0 wk, 24 wk | 
| change from baseline to week 24 in Fasting serum pro-insulin |  | 0 wk, 24wk | 
| change in from baseline to week 24 fasting serum c-peptide |  | 0wk, 24wk | 
| change from baseline to week 24 in HOMA-β |  | owjm 24wk | 
| change from baseline to week 24 in HOMA-IR |  | 0wk, 24 wk | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CWP-0403, type 2 DM, Efficacy, Safety, Phase 3