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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01529541
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 compared to Sitagliptin by proving non-inferiority in patients with type 2 Diabetes Mellitus insufficiently controlled with metformin alone.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Anagliptin
Drug: Sitagliptin
 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, 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

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<7% at week24 [ Time Frame: 0wk, 8wk, 16wk, 24wk ] [ Designated as safety issue: No ]
  • The proportion of subjects achieving HbA1c<6.5% 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: Fasting serum insulin [ Time Frame: 0wk, 24 wk ] [ Designated as safety issue: No ]
  • change from baseline to week 24 in Fasting serum pro-insulin [ Time Frame: 0wk, 24wk ] [ Designated as safety issue: No ]
  • change from baseline to week 24 in Fasting serum c-peptide [ Time Frame: 0wk, 24wk ] [ Designated as safety issue: No ]
  • change from baseline to week 24 in HOMA-β [ Time Frame: 0wk, 24 wk ] [ Designated as safety issue: No ]
  • change from baseline to week 24 in HOMA-IR [ Time Frame: 0wk, 24 wk ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sitagliptin
Sitagliptin 100mg
 Drug: Sitagliptin
Sitagliptin 100mg, tablet, once a day (QD)
Experimental: CWP-0403
CWP-0403 100mg
 Drug: Anagliptin
Anagliptin 100mg, tablet, twice a day (BID)

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529541

Locations
Korea, Republic of
Kangbuk Samsung Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
JW Pharmaceutical
  More Information

No publications provided

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT01529541     History of Changes
Other Study ID Numbers: CWP-DIANA-302
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
Sitagliptin
Metformin
type 2 DM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Metformin
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013