Efficacy and Safety of Lobeglitazone Versus Sitagliptin

July 6, 2015 updated by: Chong Kun Dang Pharmaceutical

Efficacy and Safety of Lobeglitazone Versus Sitagliptin in Inadequately Controlled by Metformin Alone Type 2 Diabetes Mellitus Patients With Metabolic Syndrome: 24-week, Multi-center, Randomized, Double-blind, Phase 4 Study

Efficacy and Safety of Lobeglitazone versus Sitagliptin in inadequately controlled by Metformin alone Type 2 Diabetes mellitus Patients with Metabolic syndrome.

Study Overview

Status

Status

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

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.

Detailed Description

Efficacy and Safety of Lobeglitazone versus Sitagliptin in inadequately controlled by Metformin alone Type 2 Diabetes mellitus Patients with Metabolic syndrome: 24-week, Multi-center, Randomized, Double-blind, Phase 4 Study.

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 (Anticipated)

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.
248

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 4

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
          • Dong-sub Choi

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:

  • ≥19 years old
  • Waist line: male ≥ 90cm, female ≥ 85cm

  • Applied to 1 or more categories listed below (NCEP-ATP III)

    1. SBP ≥ 130mmHg and/or DBP ≥ 85mmHg and/or taking drug for BP control
    2. HDL-C: male < 40mg/dl, female < 50mg/dl and/or taking drug for HDL-C increase
    3. TG ≥ 150mg/dl and/or taking drug for TG control

  • At visit 1: Applied to 1 or more categories listed below

    1. Type 2 DM Patients who does not need stabilization period : 7% ≤ HbA1c ≤ 10%, if treated with Metformin ≥ 1000mg monotherapy at least 12 weeks prior to this study → Visit 3(Randomization)
    2. Type 2 DM Patients who need stabilization period : 7% ≤ HbA1c ≤ 10%, if not treated with Metformin ≥ 1000mg monotherapy at least 12 weeks prior to this study (Applied to 1 or more categories listed below) ① Drug Naïve ② Taking Metformin < 1000mg monotherapy and/or Taking Metformin < 12 weeks prior to this study ③ Taking OHA
  • At visit 2(After 12 weeks of stabilization period): 7% ≤ HbA1c ≤ 10%
  • Patients who signed informed consent form

Exclusion Criteria:

  • Type 1 DM Patients or secondary DM
  • Patients with ketoacidosis
  • Patients with taking insulin > 7 days within 12 weeks
  • Hypersensitive to biguanide and/or glitazone and/or DPP4-inhibitor
  • Patients with taking corticosteroid > 7 days within 4 weeks
  • Patients with lactic acidosis
  • Patients with galactose intolerance and/or Lapp lactase deficiency and/or glucose-galactose malabsorption
  • Patients with innutrition and/or starvation and/or weakness and/or pituitary insufficiency and/or addisons disease
  • History of malignant tumor within 5 years
  • History of drug or alcohol abuse within 12 weeks
  • Patients with congestive heart failure(NYHA class III~IV) or uncontrolled arrythmia within 6 months
  • Patients with acute cardiovasvular disaese with 12 weeks

  • Applied to 1 or more categories listed below

    1. AST and/or ALT ≥ 3*ULN
    2. Serum creatinine: male ≥ 1.5mg/dl, female ≥ 1.4mg/dl
    3. Hb < 10.5g/dl
  • Women with pregnant, breast-feeding
  • Childbearing age who don't use adequate contraception
  • Patients who have participated in other clinical trials
  • Not eligible to participate for the study at the discretion of 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: 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.
EXPERIMENTAL: Lobelitazone 0.5mg
Drug: Lobelitazone 0.5mg
Lobelitazone 0.5mg, placebo of Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin
ACTIVE_COMPARATOR: Sitagliptin 100mg
Drug: Sitagliptin 100mg
placebo of Lobelitazone 0.5mg, Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin

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
The mean percent change of HbA1c
Time Frame: from baseline at 24 weeks
from baseline at 24 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
The rate of Metabolic Syndrome
Time Frame: from baseline at 24 weeks
from baseline at 24 weeks
The mean percent change of Metabolic Syndrome Components(HDL-C, TG, BP, waist line)
Time Frame: from baseline at 24 weeks
from baseline at 24 weeks
The mean percent change of Glycemic parameters(FPG, HOMA-IR, HOMA- β, QUICKI)
Time Frame: from baseline at 24 weeks
from baseline at 24 weeks
The mean percent change of Lipid parameters(Total Cholesterol, LDL-C, HDL-C, Small Dense LDL-C, FFA, Apo-B)
Time Frame: from baseline at 24 weeks
from baseline at 24 weeks
The achivement rate of HbA1c(HbA1c < 6.5%, HbA1c < 7%)
Time Frame: from baseline at 24 weeks
from baseline at 24 weeks
The mean percent change of Adiponectin
Time Frame: from baseline at 24 weeks
from baseline at 24 weeks
The mean percent change of hs-CRP
Time Frame: from baseline at 24 weeks
from baseline at 24 weeks
Safety evaluation - physical examination, vital sign, laboratory, adverse event
Time Frame: from baseline at 24 weeks
from baseline at 24 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.
  • Principal Investigator: Dong-Sub Choi, 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.
January 1, 2015

Primary Completion (ANTICIPATED)

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.
December 1, 2016

Study Completion (ANTICIPATED)

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.
March 1, 2017

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).
June 22, 2015

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.
June 23, 2015

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.
June 24, 2015

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.
July 8, 2015

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.
July 6, 2015

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.
May 1, 2015

More Information

Terms related to this study

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.
  • 39DM14010

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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