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:
Information provided by (Responsible Party):
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01529541
First received: February 6, 2012
Last updated: May 12, 2014
Last verified: May 2014
  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:


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
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

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
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: 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: May 12, 2014
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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014