- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01529528
A Study to Efficacy and Safety of CWP-0403 in Type 2 Diabetes Mellitus Patients (CWP-DIANA-301)
January 2, 2013 updated by: JW Pharmaceutical
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
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
117
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Kangbuk Samsung Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo of CWP-0403 100mg
|
Placebo of Anagliptin 100mg, tablet, BID
|
Experimental: CWP-0403 200mg
|
Anagliptin 100mg, tablet, BID
|
Experimental: CWP-0403 100mg
|
Anagliptin 100mg, tablet, BID
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The Change in HbA1c from baseline to week24
Time Frame: 0wk, 8wk, 16wk, 24wk
|
0wk, 8wk, 16wk, 24wk
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The proportion of subjects achieving HbA1c<7% at week24
Time Frame: 0wk, 8wk, 16wk, 24wk
|
0wk, 8wk, 16wk, 24wk
|
The proportion of subjects achieving HbA1c<6.5% at week24
Time Frame: 0wk, 8wk, 16wk, 24wk
|
0wk, 8wk, 16wk, 24wk
|
The change from baseline to week 24: Fasting plasma glucose
Time Frame: 0wk, 24wk
|
0wk, 24wk
|
change from baseline to week 24 in HOMA-IR
Time Frame: 0wk, 24 wk
|
0wk, 24 wk
|
change from baseline to week 24 in Fasting serum insulin
Time Frame: 0 wk, 24 wk
|
0 wk, 24 wk
|
change from baseline to week 24 in Fasting serum pro-insulin
Time Frame: 0 wk, 24wk
|
0 wk, 24wk
|
change in from baseline to week 24 fasting serum c-peptide
Time Frame: 0wk, 24wk
|
0wk, 24wk
|
change from baseline to week 24 in HOMA-β
Time Frame: owjm 24wk
|
owjm 24wk
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sung Woo Park, M.D., PhD, Kangbuk Samsung Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
February 6, 2012
First Submitted That Met QC Criteria
February 8, 2012
First Posted (Estimate)
February 9, 2012
Study Record Updates
Last Update Posted (Estimate)
January 4, 2013
Last Update Submitted That Met QC Criteria
January 2, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CWP-DIANA-301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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