Diabetes Mellitus Type 2Phase 1NCT02827890
CKD-396 Drug-drug Interaction Study(B) (CKD-396 DDI(B) P1)
A Phase 1 study testing Januvia Tab. 100mg and Januvia Tab. 100mg + Duvie Tab. 0.5mg in people with Diabetes Mellitus Type 2, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate a pharmacokinetic drug interaction between sitagliptin and lobeglitazone 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 2
- What is being tested?
- Januvia Tab. 100mg and Januvia Tab. 100mg + Duvie Tab. 0.5mg
- 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(a. 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.
- Whose blood pressure ≤ 100 or ≥150(systolic blood pressure) or < 60 or ≥ 100(diastolic blood pressure).
Show all 21Show fewer
- 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 the ingredients of Sitagliptin or thiazolidinediones drugs or drugs that contain Rosiglitazone or dugs that have similar effect a Rosiglitazone(Pioglitazone).
- 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.
About this study
Official title: A Randomized, Open-label, Multiple Dosing, 2-way Crossover Study to Evaluate the Effect of Lobeglitazoneon Pharmacokinetics of Sitagliptin in Healthy Male Volunteers
The purpose of this study is to evaluate a pharmacokinetic drug interaction between sitagliptin and lobeglitazone 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.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Januvia Tab. 100mg, Januvia Tab. 100mg + Duvie Tab. 0.5mg
- 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.
Januvia Tab. 100mgDrug
Also called Sitagliptin 100mg
Januvia Tab. 100mg*1T/day for 5days, QD, PO
Januvia Tab. 100mg + Duvie Tab. 0.5mgDrug
Also called Sitagliptin 100mg, Lobeglitazone 0.5mg
Januvia Tab.100mg + Duvie Tab. 0.5mg*1T/day for 5 dyas, QD, PO
| Study group | Role | What they receive |
|---|---|---|
| Group 1(Treatment A/Treatment B) | Experimental | Period 1: Treatment A(Januvia Tab. 100mg)*1T/day for 5 days, QD, PO.
Period 2: Treatment B(Januvia Tab. 100mg + Duvie Tab. 0.5mg)*1T/day for 5 dyas, QD, PO.
Each treatment period was separated by a washout period of at least 10 dyas. Receives: Drug: Januvia Tab. 100mg; Drug: Januvia Tab. 100mg + Duvie Tab. 0.5mg |
| Group 2(Treatment B/Treatment A) | Experimental | Period 1: Treatment B(Januvia Tab. 100mg + Duvie Tab. 0.5mg)*1T/day for 5 dyas, QD, PO.
Period 2: Treatment A(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: Januvia Tab. 100mg; Drug: Januvia Tab. 100mg + Duvie Tab. 0.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ of Sitagliptin
Measured: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Css,max of Sitagliptin
Measured: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Secondary outcomes (8)
Css,min of Sitagliptin
Measured: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Css,av of Sitagliptin
Measured: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Tss,max of Sitagliptin
Measured: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
t1/2 of Sitagliptin
Measured: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
CLss/F of Sitagliptin
Measured: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Vdss/F of Sitagliptin
Measured: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
fluctuation[(Css,max-Css,min)/Css,av] of Sitagliptin
Measured: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
swing[(Css,max-Css,min)/Css,min] of Sitagliptin
Measured: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 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.
- First posted11 Jul 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-Gul Kim, MD,PhD, Study director, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827890
- Sponsor's protocol ID
- 165DDI16003
- Status last verified
- Aug 2017
- First submitted
- 30 Jun 2016
- Last updated
- 9 Aug 2017
- 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple Dosing, 2-way Crossover Study to Evaluate the Effect of Lobeglitazoneon Pharmacokinetics of Sitagliptin in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02827890
- Acronym / sponsor ID
- 165DDI16003
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate a pharmacokinetic drug interaction between sitagliptin and lobeglitazone in healthy male volunteers.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1(Treatment A/Treatment B) | Experimental | Drug: Januvia Tab. 100mg, Drug: Januvia Tab. 100mg + Duvie Tab. 0.5mgPeriod 1: Treatment A(Januvia Tab. 100mg)*1T/day for 5 days, QD, PO. Period 2: Treatment B(Januvia Tab. 100mg + Duvie Tab. 0.5mg)*1T/day for 5 dyas, QD, PO. Each treatment period was separated by a washout period of at least 10 dyas. |
| Group 2(Treatment B/Treatment A) | Experimental | Drug: Januvia Tab. 100mg, Drug: Januvia Tab. 100mg + Duvie Tab. 0.5mgPeriod 1: Treatment B(Januvia Tab. 100mg + Duvie Tab. 0.5mg)*1T/day for 5 dyas, QD, PO. Period 2: Treatment A(Januvia Tab. 100mg)*1T/day for 5 dyas, QD, PO. Each treatment period was separated by a washout period of at least 10 dyas. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (21 listed)
- 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(a. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Januvia Tab. 100mgAlso: Sitagliptin 100mgJanuvia Tab. 100mg*1T/day for 5days, QD, PO | Drug | Group 1(Treatment A/Treatment B), Group 2(Treatment B/Treatment A) |
| Januvia Tab. 100mg + Duvie Tab. 0.5mgAlso: Sitagliptin 100mg, Lobeglitazone 0.5mgJanuvia Tab.100mg + Duvie Tab. 0.5mg*1T/day for 5 dyas, QD, PO | Drug | Group 1(Treatment A/Treatment B), Group 2(Treatment B/Treatment A) |
Primary outcome
AUCτ of Sitagliptin
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Css,max of Sitagliptin
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
8 secondary outcomes
Css,min of Sitagliptin
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Css,av of Sitagliptin
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Tss,max of Sitagliptin
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
t1/2 of Sitagliptin
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
CLss/F of Sitagliptin
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Vdss/F of Sitagliptin
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
fluctuation[(Css,max-Css,min)/Css,av] of Sitagliptin
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
swing[(Css,max-Css,min)/Css,min] of Sitagliptin
Time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 48h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Derived from this study: PubMed 32362346Moon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min-Gul Kim, MD,PhD study director
Chonbuk National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Januvia Tab. 100mg and Januvia Tab. 100mg + Duvie Tab. 0.5mg in people with Diabetes Mellitus Type 2, 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 21 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 9 Aug 2017. 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 Sitagliptin (time frame: 1Day 0h, 3Day 0h, 4Day 0h, 5Day 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 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 NCT02827890, 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 9 Aug 2017.