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CompletedNCT01529528CWP-DIANA-301Updated Jan 4, 2013

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

A Phase 3 interventional study of Anagliptin and Anagliptin in Type 2 Diabetes Mellitus, sponsored by JW Pharmaceutical. Completed at 1 site in South Korea. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-01-04.

Sponsored by JW Pharmaceutical · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
117
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • CWP-0403
  • type 2 DM
  • Efficacy
  • Safety
  • Phase 3
03

In context

Diabetes Mellitus, Type 2

9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 117 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

JW Pharmaceutical is the lead sponsor of 77 studies on the registry; 6 are open to participants now.

Browse JW Pharmaceutical studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
117 participants (actual)

Study arms

  • Placebo comparator
    Placebo of CWP-0403 100mg

    Placebo of CWP-0403 100mg

    Drug: Placebo of Anagliptin

  • Experimental
    CWP-0403 200mg

    CWP-0403 200mg

    Drug: Anagliptin

  • Experimental
    CWP-0403 100mg

    CWP-0403 100mg

    Drug: Anagliptin

Interventions

  • DrugAnagliptin

    Anagliptin 100mg, tablet, BID

  • DrugAnagliptin

    Anagliptin 100mg, tablet, BID

  • DrugPlacebo of Anagliptin

    Placebo of Anagliptin 100mg, tablet, BID

06

What researchers measure

Primary outcomes

  1. The Change in HbA1c from baseline to week24

    Time frame: 0wk, 8wk, 16wk, 24wk

Secondary outcomes

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

    Time frame: 0wk, 8wk, 16wk, 24wk

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

    Time frame: 0wk, 8wk, 16wk, 24wk

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

    Time frame: 0wk, 24wk

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

    Time frame: 0 wk, 24 wk

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

    Time frame: 0 wk, 24wk

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

    Time frame: 0wk, 24wk

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

    Time frame: owjm 24wk

  8. change from baseline to week 24 in HOMA-IR

    Time frame: 0wk, 24 wk

07

Study locations

1 site
  • Kangbuk Samsung Hospital
    Seoul, South Korea
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2011, a primary completion of Sep 2012 and a completion of Nov 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 6, 2012
First posted
Feb 9, 2012
Start
May 2011
Primary completionActual
Sep 2012
CompletionActual
Nov 2012
Last update
Jan 4, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01529528
Lead sponsor
JW Pharmaceutical
Responsible party
Sponsor
First posted
Feb 9, 2012
Start date
May 2011
Primary completion
Sep 2012
Completion
Nov 2012
Last update
Jan 4, 2013

Study contacts

Sung Woo Park, M.D., PhD
principal investigator · Kangbuk Samsung Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Anagliptin

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