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Efficacy and Safety of CKD-501 Versus Pioglitazone When Added to Metformin

NCT01106131 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2013-02-15

No results posted yet for this study

Summary

The purpose of this study is to prove effect of glucose reduction that CKD-501 and metformin combination treatment group is non inferiority compare to pioglitazone and metformin combination.

Conditions

Interventions

DRUG

CKD-501 0.5mg

CKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with metformin.

DRUG

Pioglitazone 15mg

Pioglitazone 15mg, orally, 1 tablet or 2 tablet(if confirmed case) once a day for 24weeks with metformin.

Sponsors & Collaborators

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • SungWoo Park, M.D., Ph.D. · Kangbuk Samsung Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-04-30
Completion
2012-11-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01106131 on ClinicalTrials.gov