A Study to Efficacy and Safety of CWP-0403 in Type 2 Diabetes Mellitus Patients (CWP-DIANA-301)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01529528
First received: February 6, 2012
Last updated: January 2, 2013
Last verified: January 2013

February 6, 2012
January 2, 2013
May 2011
September 2012   (final data collection date for primary outcome measure)
The Change in HbA1c from baseline to week24 [ Time Frame: 0wk, 8wk, 16wk, 24wk ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01529528 on ClinicalTrials.gov Archive Site
  • The proportion of subjects achieving HbA1c<6.5% at week24 [ Time Frame: 0wk, 8wk, 16wk, 24wk ] [ Designated as safety issue: No ]
  • The proportion of subjects achieving HbA1c<7% at week24 [ Time Frame: 0wk, 8wk, 16wk, 24wk ] [ Designated as safety issue: No ]
  • The change from baseline to week 24: Fasting plasma glucose [ Time Frame: 0wk, 24wk ] [ Designated as safety issue: No ]
  • change from baseline to week 24 in Fasting serum insulin [ Time Frame: 0 wk, 24 wk ] [ Designated as safety issue: No ]
  • change from baseline to week 24 in Fasting serum pro-insulin [ Time Frame: 0 wk, 24wk ] [ Designated as safety issue: No ]
  • change in from baseline to week 24 fasting serum c-peptide [ Time Frame: 0wk, 24wk ] [ Designated as safety issue: No ]
  • change from baseline to week 24 in HOMA-β [ Time Frame: owjm 24wk ] [ Designated as safety issue: No ]
  • change from baseline to week 24 in HOMA-IR [ Time Frame: 0wk, 24 wk ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Efficacy and Safety of CWP-0403 in Type 2 Diabetes Mellitus Patients
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Anagliptin
    Anagliptin 100mg, tablet, BID
  • Drug: Placebo of Anagliptin
    Placebo of Anagliptin 100mg, tablet, BID
  • Placebo Comparator: Placebo of CWP-0403 100mg
    Placebo of CWP-0403 100mg
    Intervention: Drug: Placebo of Anagliptin
  • Experimental: CWP-0403 200mg
    CWP-0403 200mg
    Intervention: Drug: Anagliptin
  • Experimental: CWP-0403 100mg
    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
117
November 2012
September 2012   (final data collection date for primary outcome measure)

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:

  • 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
Both
19 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01529528
CWP-DIANA-301
No
JW Pharmaceutical
JW Pharmaceutical
Not Provided
Principal Investigator: Sung Woo Park, M.D., PhD Kangbuk Samsung Hospital
JW Pharmaceutical
January 2013

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