Efficacy and Safety of CWP-0403 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin Alone (CWP-DIANA-302)

May 12, 2014 updated by: JW Pharmaceutical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Change in HbA1c from baseline to week24.
Time Frame: 0wk, 8wk, 16wk, 24wk
0wk, 8wk, 16wk, 24wk

Secondary Outcome Measures

Outcome Measure
Time Frame
The proportion of subjects achieving HbA1c<7% at week24
Time Frame: 0wk, 8wk, 16wk, 24wk
0wk, 8wk, 16wk, 24wk
The proportion of subjects achieving HbA1c<6.5% at week24
Time Frame: 0wk, 8wk, 16wk, 24wk
0wk, 8wk, 16wk, 24wk
The change from baseline to week 24: Fasting plasma glucose
Time Frame: 0wk, 24wk
0wk, 24wk
change from baseline to week 24: Fasting serum insulin
Time Frame: 0wk, 24 wk
0wk, 24 wk
change from baseline to week 24 in Fasting serum pro-insulin
Time Frame: 0wk, 24wk
0wk, 24wk
change from baseline to week 24 in Fasting serum c-peptide
Time Frame: 0wk, 24wk
0wk, 24wk
change from baseline to week 24 in HOMA-β
Time Frame: 0wk, 24 wk
0wk, 24 wk
change from baseline to week 24 in HOMA-IR
Time Frame: 0wk, 24 wk
0wk, 24 wk

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

February 6, 2012

First Submitted That Met QC Criteria

February 8, 2012

First Posted (ESTIMATE)

February 9, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 14, 2014

Last Update Submitted That Met QC Criteria

May 12, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CWP-DIANA-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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