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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
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:


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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: May 2011
Study Completion Date: October 2013
Primary Completion Date: May 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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529541


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

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT01529541     History of Changes
Other Study ID Numbers: CWP-DIANA-302
First Submitted: February 6, 2012
First Posted: February 9, 2012
Last Update Posted: May 14, 2014
Last Verified: May 2014

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
Metformin
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action