A Study to Efficacy and Safety of CWP-0403 in Type 2 Diabetes Mellitus Patients
CWP-DIANA-301
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
1 other identifier
interventional
117
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 type-2-diabetes-mellitus
Started May 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 6, 2012
CompletedFirst Posted
Study publicly available on registry
February 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedJanuary 4, 2013
January 1, 2013
1.3 years
February 6, 2012
January 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Change in HbA1c from baseline to week24
0wk, 8wk, 16wk, 24wk
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (3)
Placebo of CWP-0403 100mg
PLACEBO COMPARATORPlacebo of CWP-0403 100mg
CWP-0403 200mg
EXPERIMENTALCWP-0403 200mg
CWP-0403 100mg
EXPERIMENTALCWP-0403 100mg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kangbuk Samsung Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sung Woo Park, M.D., PhD
Kangbuk Samsung Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2012
First Posted
February 9, 2012
Study Start
May 1, 2011
Primary Completion
September 1, 2012
Study Completion
November 1, 2012
Last Updated
January 4, 2013
Record last verified: 2013-01