Type 2 Diabetes MellitusPhase 2NCT00888719
Therapeutic Exploratory Study of CWP-0403
A Phase 2 study testing CWP-0403 100mg and CWP-0403 50mg in people with Type 2 Diabetes Mellitus, run by JW Pharmaceutical at 10 sites in South Korea.
Trial summary
Objective of the trial is to assess dose-dependency, efficacy and safety and to estimate optimum dosage for confirmatory study of CWP-0403 50mg, 100mg given twice daily for 12 weeks to type 2 diabetes patients who are insufficiently controlled by diet and exercise in comparison to placebo. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- CWP-0403 100mg and CWP-0403 50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Feb 2009to Apr 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of≥25 and <75 with typeⅡ DM patients
- Patients whose level of HbA1c is over 7.0% and less than 10% within 4weeks of screening registration
- In spite of dietary and exercise treatment over 8weeks, the level of HbA1c is over 6.5% and less than 10%.
- BMI between 20kg/㎡ and 40kg/㎡
- Out patients
- patients who agree the trial participation with written informed consent
Who cannot join
- TypeⅠDM, Gestational diabetes.
- Patients who are being treated with insulin
- Fasting glucose level over 250mg/dL
- Patients who are not compliant with dietary and exercise treatment during 8 weeks of screening period. (Evaluated "Bad" and worse)
- Severe hepatic dysfunctions (i.e.: uncompensated hepatic cirrhosis)or AST or ALT level over 2.5times as high as UNL on screening visit.
- Severe renal dysfunctions (i.e.: renal failure) or serum creatinine level over 1.5mg/dl
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- Severe cardiac dysfunction(i.e.: heart failure ) or history of myocardial infarction within 6months of screening
- Chronic pulmonary disease or pulmonary infarction
- Pancreatitis patients
- Patients who are being treated for life threatening disease such as cancer, severe trauma or infection.
- Uncontrollable diabetic complications(neuropathy, retinopathy, nephrosis)
- Severe ketosis or experience of diabetic coma
- Intestinal disease affecting digestion or absorption or history of GI dissection surgery except for appendectomy.
- Pregnant, expecting to be pregnant or nursing female
- Excessive alcohol consumption (Over 80g of alcohol/day: Over 1 bottle of 360ml Soju/day)
- Participants of other clinical trials within 3 months of screening
- Patients medicated with following non-concomitant medications Insulins or oral antidiabetics Oral (for more than 1 week) or IV corticosteroids (External and inhaled corticosteroids excluded) appetite suppressant exenatide or other GLP-1 analogues Other medications in development
- Hypersensitive or intolerance to DPP4 inhibitory
- patients who are decided to be inappropriate for this trial subject by the investigators
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Chonbuk National University Hospital
Seoul
Ewha Womans University Mokdong Hospital
Seoul
Gachon Medical School Gil Medical Center
Seoul
Inha University Hospital
Seoul
Korea University Guro Hospital
Seoul
Kyungpook National University Hospital
Seoul
Seoul National University Bundang Hopital
Seoul
The Catholic University of Korea, Holly Family Hospital
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
The Catholic University of Korea, St. Vincent's Hospital
Seoul
About this study
Official title: A Prospective, Randomized, Double Blinded, Multicenter and Therapeutic Exploratory Study to Comparatively Assess Efficacy and Safety of CWP-0403 in Type 2 Diabetes Patients Who Are Insufficiently Controlled by Diet and Exercise.
Objective of the trial is to assess dose-dependency, efficacy and safety and to estimate optimum dosage for confirmatory study of CWP-0403 50mg, 100mg given twice daily for 12 weeks to type 2 diabetes patients who are insufficiently controlled by diet and exercise in comparison to placebo.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- CWP-0403 100mg, placebo, CWP-0403 50mg
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CWP-0403 100mgDrug
100mg/tablet, Twice a day, 1 tablet at a time for 12 weeks
placeboDrug
Tablet not containing CWP-0403 and indistinguishable from CWP-0403 50mg, 100mg tablets.
Twice a day, 1 tablet at a time for 12 weeks
CWP-0403 50mgDrug
50mg/tablet, Twice a day, 1 tablet at a time for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| CWP-0403 50mg | Experimental | Not described Receives: Drug: CWP-0403 50mg |
| CWP-0403 100mg | Experimental | Not described Receives: Drug: CWP-0403 100mg |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c before and after treatment
Measured: 12 weeks
Secondary outcomes (5)
HbA1c target achievement rate(Ratio of the patients with HbA1c lower than 6.5% or 7%)
Measured: 12 weeks
Fasting blood glucose level change and rate of change
Measured: 12 weeks
Serum insulin, serum C-peptide level change
Measured: 12 weeks
HOMA-R and HOMA-β change rate
Measured: 12 weeks
Triglyceride, LDL-cholesterol and HDL-cholesterol change
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- KunHo Yoon, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888719
- Sponsor's protocol ID
- CWP-SKD-201
- Status last verified
- Nov 2010
- First submitted
- 27 Apr 2009
- Last updated
- 5 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double Blinded, Multicenter and Therapeutic Exploratory Study to Comparatively Assess Efficacy and Safety of CWP-0403 in Type 2 Diabetes Patients Who Are Insufficiently Controlled by Diet and Exercise.
- ClinicalTrials.gov ID
- NCT00888719
- Acronym / sponsor ID
- CWP-SKD-201
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 28 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective of the trial is to assess dose-dependency, efficacy and safety and to estimate optimum dosage for confirmatory study of CWP-0403 50mg, 100mg given twice daily for 12 weeks to type 2 diabetes patients who are insufficiently controlled by diet and exercise in comparison to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CWP-0403 50mg | Experimental | Drug: CWP-0403 50mg |
| CWP-0403 100mg | Experimental | Drug: CWP-0403 100mg |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age of≥25 and <75 with typeⅡ DM patients
- Patients whose level of HbA1c is over 7.0% and less than 10% within 4weeks of screening registration
- In spite of dietary and exercise treatment over 8weeks, the level of HbA1c is over 6.5% and less than 10%.
- BMI between 20kg/㎡ and 40kg/㎡
- Out patients
Key exclusion criteria (19 listed)
- TypeⅠDM, Gestational diabetes.
- Patients who are being treated with insulin
- Fasting glucose level over 250mg/dL
- Patients who are not compliant with dietary and exercise treatment during 8 weeks of screening period. (Evaluated "Bad" and worse)
- Severe hepatic dysfunctions (i.e.: uncompensated hepatic cirrhosis)or AST or ALT level over 2.5times as high as UNL on screening visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CWP-0403 100mg100mg/tablet, Twice a day, 1 tablet at a time for 12 weeks | Drug | CWP-0403 100mg |
| placeboTablet not containing CWP-0403 and indistinguishable from CWP-0403 50mg, 100mg tablets. Twice a day, 1 tablet at a time for 12 weeks | Drug | placebo |
| CWP-0403 50mg50mg/tablet, Twice a day, 1 tablet at a time for 12 weeks | Drug | CWP-0403 50mg |
Primary outcome
Change in HbA1c before and after treatment
Time frame: 12 weeks
5 secondary outcomes
HbA1c target achievement rate(Ratio of the patients with HbA1c lower than 6.5% or 7%)
Time frame: 12 weeks
Fasting blood glucose level change and rate of change
Time frame: 12 weeks
Serum insulin, serum C-peptide level change
Time frame: 12 weeks
HOMA-R and HOMA-β change rate
Time frame: 12 weeks
Triglyceride, LDL-cholesterol and HDL-cholesterol change
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KunHo Yoon principal investigator
The Catholic University of Korea
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CWP-0403 100mg and CWP-0403 50mg in people with Type 2 Diabetes Mellitus, run by JW Pharmaceutical at 10 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c before and after treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2010.