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Efficacy and Safety of CWP-0403 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin Alone (CWP-DIANA-302)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01529541
First Posted: February 9, 2012
Last Update Posted: May 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
JW Pharmaceutical
February 6, 2012
February 9, 2012
May 14, 2014
May 2011
May 2013   (Final data collection date for primary outcome measure)
The Change in HbA1c from baseline to week24. [ Time Frame: 0wk, 8wk, 16wk, 24wk ]
Same as current
Complete list of historical versions of study NCT01529541 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of CWP-0403 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin Alone
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Anagliptin
    Anagliptin 100mg, tablet, twice a day (BID)
  • Drug: Sitagliptin
    Sitagliptin 100mg, tablet, once a day (QD)
  • Active Comparator: Sitagliptin
    Sitagliptin 100mg
    Intervention: Drug: Sitagliptin
  • Experimental: CWP-0403
    CWP-0403 100mg
    Intervention: Drug: Anagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
October 2013
May 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
19 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01529541
CWP-DIANA-302
No
Not Provided
Not Provided
JW Pharmaceutical
JW Pharmaceutical
Not Provided
Not Provided
JW Pharmaceutical
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP