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Type 2 Diabetes MellitusPhase 3CWP-DIANA-301NCT01529528

A Study to Efficacy and Safety of CWP-0403 in Type 2 Diabetes Mellitus Patients

A Phase 3 study testing Anagliptin in people with Type 2 Diabetes Mellitus, run by JW Pharmaceutical at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
117 participants
Where
1 siteSouth Korea
Study dates
May 2011to Nov 2012
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

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Kangbuk Samsung Hospital

    Seoul

Other trials in South Korea

About this study

Official title: 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.

Being tested
Anagliptin, Placebo of Anagliptin
Keywords
CWP-0403, type 2 DM, Efficacy, Safety, Phase 3
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, BID

  • AnagliptinDrug

    Anagliptin 100mg, tablet, BID

  • Placebo of AnagliptinDrug

    Placebo of Anagliptin 100mg, tablet, BID

Study groups in NCT01529528
Study groupRoleWhat they receive
Placebo of CWP-0403 100mgPlacebo comparatorPlacebo of CWP-0403 100mg
Receives: Drug: Placebo of Anagliptin
CWP-0403 200mgExperimentalCWP-0403 200mg
Receives: Drug: Anagliptin
CWP-0403 100mgExperimentalCWP-0403 100mg
Receives: Drug: Anagliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Change in HbA1c from baseline to week24

    Measured: 0wk, 8wk, 16wk, 24wk

Secondary outcomes (8)

  1. The proportion of subjects achieving HbA1c<6.5% at week24

    Measured: 0wk, 8wk, 16wk, 24wk

  2. The proportion of subjects achieving HbA1c<7% at week24

    Measured: 0wk, 8wk, 16wk, 24wk

  3. The change from baseline to week 24: Fasting plasma glucose

    Measured: 0wk, 24wk

  4. change from baseline to week 24 in Fasting serum insulin

    Measured: 0 wk, 24 wk

  5. change from baseline to week 24 in Fasting serum pro-insulin

    Measured: 0 wk, 24wk

  6. change in from baseline to week 24 fasting serum c-peptide

    Measured: 0wk, 24wk

  7. change from baseline to week 24 in HOMA-β

    Measured: owjm 24wk

  8. 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.

  1. First posted9 Feb 2012 (estimated)
  2. Study startMay 2011
  3. Primary completionSep 2012
  4. Study completionNov 2012

Resources

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
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01529528
Sponsor's protocol ID
CWP-DIANA-301
Acronym
CWP-DIANA-301
Status last verified
Jan 2013
First submitted
6 Feb 2012
Last updated
4 Jan 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Anagliptin 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 5 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 4 Jan 2013. 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. 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 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?

On the ClinicalTrials.gov record for NCT01529528.

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 4 Jan 2013.

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