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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Anagliptin
Drug: Placebo of Anagliptin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:
  • The Change in HbA1c from baseline to week24 [ Time Frame: 0wk, 8wk, 16wk, 24wk ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 117
Study Start Date: May 2011
Study Completion Date: November 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo of CWP-0403 100mg
Placebo of CWP-0403 100mg
Drug: Placebo of Anagliptin
Placebo of Anagliptin 100mg, tablet, BID
Experimental: CWP-0403 200mg
CWP-0403 200mg
Drug: Anagliptin
Anagliptin 100mg, tablet, BID
Experimental: CWP-0403 100mg
CWP-0403 100mg
Drug: Anagliptin
Anagliptin 100mg, tablet, BID

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529528

Locations
Korea, Republic of
Kangbuk Samsung Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
JW Pharmaceutical
Investigators
Principal Investigator: Sung Woo Park, M.D., PhD Kangbuk Samsung Hospital
  More Information

No publications provided

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT01529528     History of Changes
Other Study ID Numbers: CWP-DIANA-301
Study First Received: February 6, 2012
Last Updated: January 2, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by JW Pharmaceutical:
CWP-0403
type 2 DM
Efficacy
Safety
Phase 3

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 24, 2014