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

NCT ID: NCT01529541

Last Updated: 2014-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Sitagliptin

Sitagliptin 100mg

Group Type ACTIVE_COMPARATOR

Sitagliptin

Intervention Type DRUG

Sitagliptin 100mg, tablet, once a day (QD)

CWP-0403

CWP-0403 100mg

Group Type EXPERIMENTAL

Anagliptin

Intervention Type DRUG

Anagliptin 100mg, tablet, twice a day (BID)

Interventions

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Anagliptin

Anagliptin 100mg, tablet, twice a day (BID)

Intervention Type DRUG

Sitagliptin

Sitagliptin 100mg, tablet, once a day (QD)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JW Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CWP-DIANA-302

Identifier Type: -

Identifier Source: org_study_id

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