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An Evaluation of Glycemic Control Effects of Mono Therapy CKD-501 in Patients With Type 2 Diabetes Mellitus

NCT01001611 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2013-07-19

No results posted yet for this study

Summary

The purpose of this study is to evaluate and confirm hypoglycemic efficacy and safety of CKD-501 as mono therapy in patients with type 2 diabetes treated once daily for 24 weeks in comparison to placebo.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

CKD-501 0.5mg

0.5 mg/tablet, orally, 1 tablet once daily for 24 weeks or 52 weeks (If extension study)

DRUG

Placebo

Indistinguishable tablet from CKD-501, Orally, 1 tablet once daily for 24 weeks

Sponsors & Collaborators

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Dongseop Choi · The Korea University Anam 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
2009-10-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

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 NCT01001611 on ClinicalTrials.gov