Type 2 Diabetes MellitusPhase 3CWP-DIANA-302NCT01529541
Efficacy and Safety of CWP-0403 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin Alone
A Phase 3 study testing Anagliptin and Sitagliptin in people with Type 2 Diabetes Mellitus, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
This trial is to evaluate the efficacy and safety of CWP-0403 compared to Sitagliptin by proving non-inferiority in patients with type 2 Diabetes Mellitus insufficiently controlled with metformin alone. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Anagliptin and Sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Oct 2013
- Phase
- Phase 3
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who had diagnosed with type 2 DM before 3 months
- Men and women between the age of ≥ 19 and ≤ 75 years
- FPG ≤ 270 mg/dL at screening visit
- Patients who consent to participate in this trial by written Informed Consent Form
Who cannot join
- Type 1 DM or secondary diabetes
- Subjects who are administrating oral anti-hyperglycemic drugs or have to take a medicine
- Body mass index < 20 kg/m2 or > 40.0kg/m2
- Subjects who are assessed to be inappropriate for this trial by investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Double Dummy, Active-controlled, Therapeutic Confirmatory Trial(Phase 3) to Evaluate the Efficacy and Safety of CWP-0403 Compared With Sitagliptin Added to Ongoing Metformin Therapy in Patients With Type 2 DM Insufficiently Controlled With Metformin Alone
This trial is to evaluate the efficacy and safety of CWP-0403 compared to Sitagliptin by proving non-inferiority in patients with type 2 Diabetes Mellitus insufficiently controlled with metformin alone.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Anagliptin, Sitagliptin
- Keywords
- CWP-0403, Sitagliptin, Metformin, type 2 DM
- 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.
AnagliptinDrug
Anagliptin 100mg, tablet, twice a day (BID)
SitagliptinDrug
Sitagliptin 100mg, tablet, once a day (QD)
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Active comparator | Sitagliptin 100mg Receives: Drug: Sitagliptin |
| CWP-0403 | Experimental | CWP-0403 100mg Receives: Drug: Anagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in HbA1c from baseline to week24.
Measured: 0wk, 8wk, 16wk, 24wk
Secondary outcomes (8)
The proportion of subjects achieving HbA1c<7% at week24
Measured: 0wk, 8wk, 16wk, 24wk
The proportion of subjects achieving HbA1c<6.5% at week24
Measured: 0wk, 8wk, 16wk, 24wk
The change from baseline to week 24: Fasting plasma glucose
Measured: 0wk, 24wk
change from baseline to week 24: Fasting serum insulin
Measured: 0wk, 24 wk
change from baseline to week 24 in Fasting serum pro-insulin
Measured: 0wk, 24wk
change from baseline to week 24 in Fasting serum c-peptide
Measured: 0wk, 24wk
change from baseline to week 24 in HOMA-β
Measured: 0wk, 24 wk
change from baseline to week 24 in HOMA-IR
Measured: 0wk, 24 wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startMay 2011
- Primary completionMay 2013
- Study completionOct 2013
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529541
- Sponsor's protocol ID
- CWP-DIANA-302
- Acronym
- CWP-DIANA-302
- Status last verified
- May 2014
- First submitted
- 6 Feb 2012
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Double Dummy, Active-controlled, Therapeutic Confirmatory Trial(Phase 3) to Evaluate the Efficacy and Safety of CWP-0403 Compared With Sitagliptin Added to Ongoing Metformin Therapy in Patients With Type 2 DM Insufficiently Controlled With Metformin Alone
- ClinicalTrials.gov ID
- NCT01529541
- Acronym / sponsor ID
- CWP-DIANA-302 / CWP-DIANA-302
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- CWP-0403, Sitagliptin, Metformin, type 2 DM
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 9 Feb 2012 (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.
This trial is to evaluate the efficacy and safety of CWP-0403 compared to Sitagliptin by proving non-inferiority in patients with type 2 Diabetes Mellitus insufficiently controlled with metformin alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin | Active comparator | Drug: SitagliptinSitagliptin 100mg |
| CWP-0403 | Experimental | Drug: AnagliptinCWP-0403 100mg |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who had diagnosed with type 2 DM before 3 months
- Men and women between the age of ≥ 19 and ≤ 75 years
- FPG ≤ 270 mg/dL at screening visit
- Patients who consent to participate in this trial by written Informed Consent Form
Key exclusion criteria (4 listed)
- Type 1 DM or secondary diabetes
- Subjects who are administrating oral anti-hyperglycemic drugs or have to take a medicine
- Body mass index < 20 kg/m2 or > 40.0kg/m2
- Subjects who are assessed to be inappropriate for this trial by investigator
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 |
|---|---|---|
| AnagliptinAnagliptin 100mg, tablet, twice a day (BID) | Drug | CWP-0403 |
| SitagliptinSitagliptin 100mg, tablet, once a day (QD) | Drug | Sitagliptin |
Primary outcome
The Change in HbA1c from baseline to week24.
Time frame: 0wk, 8wk, 16wk, 24wk
8 secondary outcomes
The proportion of subjects achieving HbA1c<7% at week24
Time frame: 0wk, 8wk, 16wk, 24wk
The proportion of subjects achieving HbA1c<6.5% at week24
Time frame: 0wk, 8wk, 16wk, 24wk
The change from baseline to week 24: Fasting plasma glucose
Time frame: 0wk, 24wk
change from baseline to week 24: Fasting serum insulin
Time frame: 0wk, 24 wk
change from baseline to week 24 in Fasting serum pro-insulin
Time frame: 0wk, 24wk
change from baseline to week 24 in Fasting serum c-peptide
Time frame: 0wk, 24wk
change from baseline to week 24 in HOMA-β
Time frame: 0wk, 24 wk
change from baseline to week 24 in HOMA-IR
Time frame: 0wk, 24 wk
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 14 May 2014.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anagliptin and Sitagliptin in people with Type 2 Diabetes Mellitus, run by JW Pharmaceutical at 1 site 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 4 inclusion and 4 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 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The Change in HbA1c from baseline to week24. (time frame: 0wk, 8wk, 16wk, 24wk). 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 14 May 2014.