Evaluate the Glycemic Control of CKD-501 in Type 2 Diabetes Mellitus

December 14, 2009 updated by: Chong Kun Dang Pharmaceutical

To Investigate the Glycemic Control and Lipid Profile of CKD-501 Monotherapy in Patients With Type 2 Diabetes Mellitus:a Eight-week, Multicenter, Randomized, Double-blind, Parallel-Group, Placebo-controlled, Dose-ranging Study.

The purpose of this study is to assess the safety and effectiveness of three doses of CKD-501 compared to placebo in lowering fasting plasma glucose levels in people with type 2 diabetes for 8 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
214

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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

  • Korea, Republic of
      • Busan, Korea, Republic of
        • The Inje University Medical Center
      • Daegu, Korea, Republic of
        • The Yeungnam University Hospital
      • Gyeonggi-do, Korea, Republic of
        • The Chtholic University of Korea Uijeongbu St. Mary's Hospital
      • Gyeonggi-do, Korea, Republic of
        • The Seoul National Univertisy Bundang Hospital
      • Kangwon-Do, Korea, Republic of
        • The Wonju Christian Hospital
      • Seoul, Korea, Republic of
        • The Inje University Sanggye-Paik Hospital
      • Seoul, Korea, Republic of
        • The Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • The Samsung Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type Ⅱ diabetes mellitus
  • Fasting Plasma Glucose(FPG)≥ 126 and ≤ 270
  • HbA1c between 7 and 11%
  • Body mass index (BMI) in the range 21-40
  • The patients who has been taking oral hypoglycemic agent or diet therapy before minimum 1 month
  • Agreement with written informed consent

Exclusion Criteria:

  • Type I diabetes, gestational diabetes or secondary diabetes
  • Treatment with insulin(over 1month) within 3 months
  • Fasting Plasma Glucose level is over 270 mg/dl
  • Triglyceride level is 500 mg/dl and over
  • Uncontrollable hypertension
  • History of myocardial infarction, heart failure, cerebral infarction, hematencephalon or unstable angina within 6 months
  • Severe hepatic dysfunction: AST, ALT, Total bilirubin, ALP level over or equal to 3 times as high as upper normal limit(UNL)
  • Severe renal dysfunction: Renal failure or serum creatinine greater than 30% normal limit
  • Needs treatment for acute disease, uncontrolled other diseae or diabetic complications
  • In treatment concomitant drug having severe risk drug interaction with investigational drug
  • History of cancer within 5 years
  • History of drug abuse or alcoholism
  • Hepatitis B Antigen(HBsAg) test is positive
  • Treatment systemic or inhalant corticosteroids within 1 month prior to Screening
  • Patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with glitazones
  • Fertile women who not practice contraception with appropriate methods Pregnant women or nursing mothers
  • Has a contraindication to treatment investigational drug from the medical and psychogenic side
  • Participated in other trial within 4 weeks Participating in other trial at present
  • An impossible one who participates in clinical trial by legal or investigator's decision

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
orally, 1 tablet once daily for 8 weeks
Experimental: CKD-501 0.5mg
Drug: CKD-501 0.5mg
0.5 mg/tablet, orally, 1 tablet once daily for 8 weeks
Other Names:
  • Lobeglitazone
Experimental: CKD-501 1mg
Drug: CKD-501 1mg
1 mg/tablet, orally, 1 tablet once daily for 8 weeks
Other Names:
  • Lobeglitazone
Experimental: CKD-501 2mg
Drug: CKD-501 2mg
2 mg/tablet, orally, 1 tablet once daily for 8 weeks
Other Names:
  • Lobeglitazone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in fasting plasma glucose at 8 weeks
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in Glycemic parameters after 8 weeks
Time Frame: 8 weeks
8 weeks
Change from baseline in Lipid parameters after 8 weeks
Time Frame: 8 weeks
8 weeks
Adverse event profile after 8 weeks of treatment
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chong Kun Dang Pharmaceutical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Dongseop Choi, MD.,Ph.D., The Korea University Anam Hospital

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19DM05L

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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