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CompletedNCT01001611Updated Jul 19, 2013

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

A Phase 3 interventional study of CKD-501 0.5mg and Placebo in Diabetes Mellitus, Type 2, sponsored by Chong Kun Dang Pharmaceutical. Completed at 9 sites in South Korea. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-07-19.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
173
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

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.

Read the detailed description

Diabetes Mellitus is classified into type 1 diabetes and type 2 diabetes mellitus according to the causes of diabetes onset and the treatment of symptoms.

In type 2 diabetes, the combination of insulin resistance and insulin deficiency is working. Diabetes mellitus causing many complications and hospitalization is one of chronic metabolic disorder and diabetes mortality rate has been gradually increasing percentage.

CKD-501 is highly selective peroxisome proliferator-activated receptor-gamma agonist that decreases insulin resistance in the periphery and liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. In vivo, It demonstrates that CKD-501 improves even more glycemic and lipid control in comparison to rosiglitazone and pioglitazone.

The aim of this phase 3 study was to evaluate the efficacy and safety of CKD-501 once daily for 24 weeks as a monotherapy in type 2 diabetes mellitus. Furthermore, the extension study for additional 28 weeks is designed to confirm long term safety of CKD-501 as an oral hypoglycemic agent.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Diabetes Mellitus, Type 2
  • glitazone
  • Type II Diabetes
  • Hypolipidemic
  • oral hypoglycemic agent
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 173 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 299 studies on the registry; 15 are open to participants now.

Browse Chong Kun Dang Pharmaceutical studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Type Ⅱ diabetes mellitus
  • Between 18 years and 80 years old
  • The patient who has been taking oral hypoglycemic agent since 3 months with HbA1c 6.5 to 9% at screening test or who is drug naive or stopped taking oral hypoglycemic agent more then 3 months with HbA1c 7 to 10% at screening test
  • BMI between 21kg/㎡ and 40kg/㎡
  • Diagnosis of type Ⅱ diabetes before 3 months
  • C-peptide level is over 1.0 ng/ml
  • Condition for female having contraception methods, surgical sterilization or menopause
  • Condition for male agreeing to use of recommendatory and appropriate contraception method
  • Agreement with written informed consent

Exclusion criteria

Exclusion Criteria:

  • Type I diabetes, gestational diabetes or secondary diabetes
  • Treatment with insulin or thiazolidinediones within 60 days
  • Fasting Plasma Glucose level is over 250 mg/dl
  • Triglyceride level is 500 mg/dl and over
  • Uncontrollable hypertension(Although treat with antihypertension agent, systolic blood pressure greater than 140 mmHg and diastolic blood pressure greater than 90 mmHg)
  • 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 2.5 times as high as upper normal limit(UNL)
  • Severe renal dysfunction: Renal failure or serum creatinine greater than 30% normal limit
  • Anemia for any reason
  • Needs treatment for acute disease, uncontrolled other diseae or diabetic complications
  • Abnormality of thyroid function(out of normal TSH range )
  • History of proliferative diabetic retinopathy
  • 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
  • An impossible one who participates in clinical trial by legal or investigator's decision
  • Participated in other trial within 4 weeks
  • Participating in other trial at present
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
173 participants (actual)

Study arms

  • Experimental
    CKD-501 0.5mg

    Drug: CKD-501 0.5mg

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugCKD-501 0.5mg

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

    Also known as: Lobeglitazone

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Change from baseline in Glycosylated Hemoglobin (HbA1c)

    Time frame: 24 weeks

Secondary outcomes

  1. Change from baseline in HbA1c target achievement rate (HbA1c<7%)

    Time frame: 24 weeks

  2. Change from baseline in lipid parameters (Total cholesterol, Triglycerides(TG), LDL-C, HDL-C, Small Dense LDL-C, Free fatty acid(FFA), Apo-AⅠ/B/C Ⅲ)

    Time frame: 24 weeks

  3. Evaluate safety of CKD-501 from physical exam, vital sign, laboratory test, adverse event and so on

    Time frame: 24 weeks or 52 weeks

  4. Change from baseline in glycemic parameters (Fasting Plasma Glucose, C-peptide, Homeostasis Model Assessment of Insulin Resistance(HOMA-IR), Homeostasis Model Assessment of β-cell function(HOMA-β), Quantitative Insulin Check Index(QUICKI))

    Time frame: 24 weeks

07

Study locations

9 sites
  • The Inje University Busan-Paik Hospital
    Busan, South Korea
  • Soon Chun Hyang University Cheonan Hospital
    Cheonan, South Korea
  • The Hanyang University Medical Center
    Gyeonggi-do, South Korea
  • Wonju Severance Christian Hospital
    Kangwon-Do, South Korea
  • The Hallym University Medical Center
    Seoul, South Korea
  • The Inje University Sanggye-Paik Hospital
    Seoul, South Korea
  • The Korea University Anam Hospital
    Seoul, South Korea
  • The Kyung Hee University Medical Center
    Seoul, South Korea
  • The Seoul National University Bundang Hospital
    Seoul, South Korea
08

References and documents

Publications

  • Kim SG, Kim DM, Woo JT, Jang HC, Chung CH, Ko KS, Park JH, Park YS, Kim SJ, Choi DS. Efficacy and safety of lobeglitazone monotherapy in patients with type 2 diabetes mellitus over 24-weeks: a multicenter, randomized, double-blind, parallel-group, placebo controlled trial. PLoS One. 2014 Apr 15;9(4):e92843. doi: 10.1371/journal.pone.0092843. eCollection 2014. PubMed 24736628 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2009, a primary completion of Jan 2012 and a completion of Jan 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2009
First posted
Oct 26, 2009
Start
Oct 2009
Primary completionActual
Jan 2012
CompletionActual
Jan 2012
Last update
Jul 19, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01001611
Lead sponsor
Chong Kun Dang Pharmaceutical
Responsible party
Sponsor
First posted
Oct 26, 2009
Start date
Oct 2009
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Jul 19, 2013

Study contacts

Dongseop Choi
study chair · The Korea University Anam Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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