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Diabetes Mellitus, Type IIPhase 1NCT02824874

CKD-396 Drug-drug Interaction Study(A) (CKD-396 DDI(A) P1)

A Phase 1 study testing Duvie Tab. 0.5mg and Duvie Tab. 0.5mg + Januvia Tab. 100mg in people with Diabetes Mellitus, Type II, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate a pharmacokinetic drug interaction between lobeglitazone and sitagliptin in healthy male volunteers. Read more about this study

Who is it for?
Ages 19 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type II
What is being tested?
Duvie Tab. 0.5mg and Duvie Tab. 0.5mg + Januvia Tab. 100mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSouth Korea
Study dates
Apr 2016to May 2016
Phase
Phase 1
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 19 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • A healthy male whose age is over 19 years old when visiting for initial screening test
  • Body mass index(BMI) between 17.5~30.5 kg/m^2 and the body weight must be over 55kg (Body mass index (BMI) = weight (kg) / height (m)^2)
  • A male with no congenital or chronic disease in three years, no history of symptoms in internal treatment, or no knowledge in the area
  • Due to the special characteristics of drugs, the participators must be qualified to do the clinical screening after examined through hematology test and blood chemistry analysis, urinary test, the electrocardiogram (ECG), and etc.
  • The participants must be volunteered and sign in an informed consent document proven by Chonbuk National University IRB before joining a study to show that he was given informed the purpose of tests and the special characteristics of drugs.
  • The participants must have an ability and willingness to participate throughout the entire trials

Who cannot join

  • A person who had a history or symptoms of clinically aware of blood, kidney, internal secretion, gastrointestinal, urinary system, cardiovascular, liver, mental, nercous, or allergic(except subclinical seasonal allergies that is not treated at injecion) desease.
  • Who had a gistory of gastrointestinal related disease which can be affected the drug absorption (esophageal achalasia, esophagostenosis, esophageal disease, or Crohn's disease) or surgeries (except a simple appendectomy or herniotomy)
  • Who had following results after examination
  • ALT or AST > twice higher than normal value
  • Who constantly intake 210 g/week of alcohol within 6 months of the screening. (a cup of beer (5%) (250 mL) = 10 g, a shot of soju (20%) (50mL) = 8 g, a glass of wine (!2%) (125 mL) = 12g)
  • Who participated other clinical test or took testing bioequivalence drugs in 3 months before the first clinical drug trial.
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  • Whose blood pressure ≤ 100 or ≥150(systolic blood pressure) or < 60 or ≥ 100(diastolic blood pressure)
  • Who had a medical history of alcohol and drug abuses.
  • Who had taken a drug that has a control of metabolic rate (activatioh or inhibithion) in 30 days before the first taking of clinical testing durg.
  • WHo smokes more than 20 eigarettes per day.
  • Who took prescribed drugs or over-the-conuter durgs in 10 days before taking of very first clinical testing drug.
  • Who participated in whole blood donation in 2 months before the first taking of clinical testing drugs or platelet donations in 1 month before the first taking to clinical testing drugs.
  • Who has a potent to increase a danger by participating in the clinical trials or sho can interrupt interpretin test results by having serious or chronic medical and mental status or having issues in results of the screening examination.
  • Who has a histroy of an extreme sensitivity of drugs that contain Rosiglitazone or dugs that have similar effect a Rosiglitazone(Pioglitazone), or drugs that contain the ingredients of Sitagliptin or thiazolidinediones drugs.
  • Who has a serious heart failure or a congestive heart failure that must be drug-treated
  • A patient with hepatopathy.
  • A patient with wevere nephropathy.
  • Who has diabetic ketoacidosis or a diaetic coma, or type 1 diabetes, or has history of acute metablic acidosis or ketoacidosis.
  • A patient with serious infectious disease or severe injuries before and after a surgery.
  • Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders.
  • Test subjects who is not willing or unable to comply with guidelines described in this protocol.
  • A person who is not determined unsuitable to participate in this test by the researchers.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Chonbuk National University Hospital

    Jeonju

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Multiple Dosing, 2-way Crossover Study to Evaluate the Effect of Sitagliptin on Pharmacokinetics of Lobeglitazone in Healthy Male Volunteers

The purpose of this study is to evaluate a pharmacokinetic drug interaction between lobeglitazone and sitagliptin in healthy male volunteers.

Read the detailed description

To healthy male subjects of twenty(20), following treatments are administered dosing in each period and wash-out period is a minimum of 10 days.

Being tested
Duvie Tab. 0.5mg, Duvie Tab. 0.5mg + Januvia Tab. 100mg
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.

  • Duvie Tab. 0.5mgDrug

    Also called Lobeglitazone 0.5mg

    Duvie Tab. 0.5mg*1T/day for 5days, QD, PO

  • Duvie Tab. 0.5mg + Januvia Tab. 100mgDrug

    Also called Lobeglitazone 0.5mg + Sitagliptin 100mg

    Duvie Tab. 0.5mg + Januvia Tab.100mg*1T/day for 5 dyas, QD, PO

Study groups in NCT02824874
Study groupRoleWhat they receive
Group 1(Treatment A/Treatment B)ExperimentalPeriod 1: Treatment A(Duvie Tab. 0.5mg)*1T/day for 5 days, QD, PO Period 2: Treatment B(Duvie Tab. 0.5mg + Januvia Tab. 100mg)*1T/day for 5 dyas, QD, PO Each treatment period was separated by a washout period of at least 10 dyas.
Receives: Drug: Duvie Tab. 0.5mg; Drug: Duvie Tab. 0.5mg + Januvia Tab. 100mg
Group 2(Treatment B/Treatment A)ExperimentalPeriod 1: Treatment B(Duvie Tab. 0.5mg + Januvia Tab. 100mg)*1T/day for 5 dyas, QD, PO Period 2: Treatment A(Duvie Tab. 0.5mg)*1T/day for 5 days, QD, PO Each treatment period was separated by a washout period of at least 10 dyas.
Receives: Drug: Duvie Tab. 0.5mg; Drug: Duvie Tab. 0.5mg + Januvia Tab. 100mg

What is being measured

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

  1. AUCτ of Lobeglitazone

    Measured: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h

  2. Css,max of Lobeglitazone

    Measured: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h

Secondary outcomes (8)

  1. Css,min of Lobeglitazone

    Measured: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h

  2. Css,av of Lobeglitazone

    Measured: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h

  3. Tss,max of Lobeglitazone

    Measured: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h

  4. t1/2 of Lobeglitazone

    Measured: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h

  5. CLss/F of Lobeglitazone

    Measured: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h

  6. Vdss/F of Lobeglitazone

    Measured: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h

  7. fluctuation[(Css,max-Css,min)/Css,av] of Lobeglitazone

    Measured: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h

  8. swing[(Css,max-Css,min)/Css,min] of Lobeglitazone

    Measured: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h

Timeline

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

  1. First posted7 Jul 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionApr 2016
  4. Study completionMay 2016

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02824874
Sponsor's protocol ID
165DDI16002
Status last verified
Jul 2016
First submitted
30 Jun 2016
Last updated
11 Jul 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Moon SJ, Yu KS, Kim MG. An Assessment of Pharmacokinetic Interaction Between Lobeglitazone and Sitagliptin After Multiple Oral Administrations in Healthy Men. Clin Ther. 2020 Jun;42(6):1047-1057. doi: 10.1016/j.clinthera.2020.04.005. Epub 2020 Apr 30.

    PubMed 32362346

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Duvie Tab. 0.5mg and Duvie Tab. 0.5mg + Januvia Tab. 100mg in people with Diabetes Mellitus, Type II, run by Chong Kun Dang Pharmaceutical at 1 site 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 6 inclusion and 22 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 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

AUCτ of Lobeglitazone (time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h). The study lists 2 primary outcomes in all. 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 NCT02824874, 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 11 Jul 2016.

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