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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
History of Changes
  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:

U.S. FDA Resources

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
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 June 18, 2013