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Diabetes Mellitus, Type 2Phase 3NCT01001611

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

A Phase 3 study testing CKD-501 0.5mg in people with Diabetes Mellitus, Type 2, run by Chong Kun Dang Pharmaceutical at 9 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
CKD-501 0.5mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
173 participants
Where
9 sitesSouth Korea
Study dates
Oct 2009to Jan 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 24Show fewer
  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

South Korea9 sites

  • The Inje University Busan-Paik Hospital

    Busan

  • Soon Chun Hyang University Cheonan Hospital

    Cheonan

  • The Hanyang University Medical Center

    Gyeonggi-do

  • Wonju Severance Christian Hospital

    Kangwon-Do

  • The Hallym University Medical Center

    Seoul

  • The Inje University Sanggye-Paik Hospital

    Seoul

  • The Korea University Anam Hospital

    Seoul

  • The Kyung Hee University Medical Center

    Seoul

  • The Seoul National University Bundang Hospital

    Seoul

Other trials in South Korea

About this study

Official title: An Evaluation of Glycemic Control Effects of Mono Therapy CKD-501 in Patients With Type 2 Diabetes Mellitus: A 24-week, Multi Center, Randomized, Double-blind, Parallel-group, Placebo Control, Therapeutic Confirmatory Study

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.

Being tested
CKD-501 0.5mg, Placebo
Keywords
Diabetes Mellitus, Type 2, glitazone, Type II Diabetes, Hypolipidemic, oral hypoglycemic agent
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CKD-501 0.5mgDrug

    Also called Lobeglitazone

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

  • PlaceboDrug

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

Study groups in NCT01001611
Study groupRoleWhat they receive
CKD-501 0.5mgExperimentalNot described
Receives: Drug: CKD-501 0.5mg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in Glycosylated Hemoglobin (HbA1c)

    Measured: 24 weeks

Secondary outcomes (4)

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

    Measured: 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)

    Measured: 24 weeks

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

    Measured: 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))

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionJan 2012
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
173 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01001611
Sponsor's protocol ID
CKD-19DM09B
Other IDs
19DM09B
Status last verified
Jul 2013
First submitted
23 Oct 2009
Last updated
19 Jul 2013
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CKD-501 0.5mg in people with Diabetes Mellitus, Type 2, run by Chong Kun Dang Pharmaceutical at 9 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Glycosylated Hemoglobin (HbA1c) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01001611, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2013.

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