NCT01529528CompletedPhase 3
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
JW Pharmaceutical1 site in 1 country117 target enrollmentStarted: May 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 117
- Locations
- 1
- Primary Endpoint
- The Change in HbA1c from baseline to week24
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo of CWP-0403 100mg
Placebo Comparator
Placebo of CWP-0403 100mg
Intervention: Placebo of Anagliptin (Drug)
CWP-0403 200mg
Experimental
CWP-0403 200mg
Intervention: Anagliptin (Drug)
CWP-0403 100mg
Experimental
CWP-0403 100mg
Intervention: Anagliptin (Drug)
Outcomes
Primary Outcomes
The Change in HbA1c from baseline to week24
Time Frame: 0wk, 8wk, 16wk, 24wk
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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