Diabetes Mellitus, Type IIPhase 1NCT02854748

Evaluate the Drug-drugs Interaction Between Lobeglitazone and Empagliflozin

A Phase 1 study testing Empagliflozin 25mg, Lobeglitazone 0.5mg and Empagliflozin 25mg/Lobeglitazone 0.5mg in people with Diabetes Mellitus, Type II, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This study is a randomized, open-label, multiple dosing, crossover study to evaluate the drug-drugs interaction between Lobeglitazone and Empagliflozin in healthy male volunteers Read more about this study

Who is it for?: Ages 19 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type II
What is being tested?: Empagliflozin 25mg, Lobeglitazone 0.5mg and Empagliflozin 25mg/Lobeglitazone 0.5mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSouth Korea
Study dates: Aug 2016to Sep 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 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

A healthy person whose age is in between 19 to 45 during the screening tests
Whose weight is more than 55 kg, BMI is over 18.5 and under 29.9 during the screening test. (BMI (kg/m2) = 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 tests
The participants must have an ability and willingness to participate throughout the entire trials

Who cannot join

A person who has a history of clinically significant cardiovascular, respiratory, liver, kidney, endocrine system, immune system, urinary system diseases, blood-tumor diseases, mental illness.
Who had a history 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 has a history of hypersensitivity reactions to Empagliflozin or Lobeglitazone or similar series or other excipient ingredients (aspirin, fibrate, antibiotics, etc.)
A person whose electrocardiogram value includes QTc > 450 msec, PR interval > 200 msec, QRS duration > 120 msec after screening, or who show clinically significant opinion.
Who falls under the following results
Liver Function Test (AST, ALT) are exceeded over 1.5x the upper limit of the normal range

Show all 19Show fewer

eGFR < 60mL/min/1.73m2
Who shows the vital sign values of more than 150 mmHg or less than 90 mmHg in systolic pressure or more than 95 mmHg or less than 60 mmHg in diastolic blood pressure
Who has history of drug abuses or shows a positive result in the urinary drug screen
Who took any prescribed drugs, medicinal plants within the 2 weeks before the first day of dosing or takes any over-the-counter drugs or vitamin supplements within 1 week (but, if other conditions are met, they can still participate in the clinical test through the researcher's judgment)
Who took other investigational drugs or bioequivalence drugs within 3 months before the first day of dosing
Who participated in whole blood donation within 2 months before the first of dosing, or platelet donations within 1 months. Who received blood a month before the first day of dosing
Who constantly drinks alcohol (over 21 units/week, 1 unit = 10 g of pure alcohol) or cannot stop drinking alcohol during the clinical test.
Who smokes more than 10 cigarettes per day within 3 months , or who cannot quit smoking when hospitalized
Who cannot limit intake of grapefruit or grapefruit containing foods in 48hrs from the first dosing of clinical testing drug to collect pharmacokinetic blood samples
Who absorb caffeinated drinks (coffee, tea (black or green tea), soda, coffee flavored milk, energy drinks, etc.) or cannot stop absorbing them 24 hours before hospitalization until discharging
Not using a reliable contraception, planning a pregnancy during the study
Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders
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

Dong A University Hospital
Seo-gu, Busan, 49201

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Multiple Dosing, Crossover Study to Evaluate the Drug-drugs Interaction Between Lobeglitazone and Empagliflozin in Healthy Male Volunteers

This study is a randomized, open-label, multiple dosing, crossover study to evaluate the drug-drugs interaction between Lobeglitazone and Empagliflozin in healthy male volunteers

Read the detailed description

To healthy male subjects of 30, following treatments are administered dosing in each 3 period(Lobeglitazone or Empagliflozin or Lobe.+Empa.) and wash-out period is a minimum of 7 days.

Test Drug 1: Lobeglitazone 0.5mg 1T

Test Drug 2: Empagliflozin 25mg 1T

Pharmacokinetic blood samples are collected up to 24hrs.

Safety, pharmacokinetic and the drug-drugs interaction are assessed.

Conditions: Diabetes Mellitus, Type II
Being tested: Empagliflozin 25mg, Lobeglitazone 0.5mg, Empagliflozin 25mg/Lobeglitazone 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.

Empagliflozin 25mgDrug
Empagliflozin 25 mg QD for 5 days
Lobeglitazone 0.5mgDrug
Lobeglitazone 0.5mg QD for 5 days
Empagliflozin 25mg/Lobeglitazone 0.5mgDrug
Empagliflozin 25 mg + Lobeglitazone 0.5mg QD for 5 days

Study groups in NCT02854748
Study group	Role	What they receive
Empagliflozin / Lobeglitazone / Empa.+Lobe.	Experimental	Period 1: Empagliflozin 25 mg QD for 5 days Period 2: Lobeglitazone 0.5 mg QD for 5 days Period 3: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Receives: Drug: Empagliflozin 25mg; Drug: Lobeglitazone 0.5mg; Drug: Empagliflozin 25mg/Lobeglitazone 0.5mg
Empagliflozin / Empa.+Lobe. / Lobeglitazone	Experimental	Period 1: Empagliflozin 25 mg QD for 5 days Period 2: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Period 3: Lobeglitazone 0.5 mg QD for 5 days Receives: Drug: Empagliflozin 25mg; Drug: Lobeglitazone 0.5mg; Drug: Empagliflozin 25mg/Lobeglitazone 0.5mg
Lobeglitazone / Empagliflozin / Empa.+Lobe.	Experimental	Period 1: Lobeglitazone 0.5 mg QD for 5 days Period 2: Empagliflozin 25 mg QD for 5 days Period 3: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Receives: Drug: Empagliflozin 25mg; Drug: Lobeglitazone 0.5mg; Drug: Empagliflozin 25mg/Lobeglitazone 0.5mg
Lobeglitazone / Empa.+Lobe. / Empagliflozin	Experimental	Period 1: Lobeglitazone 0.5 mg QD for 5 days Period 2: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Period 3: Empagliflozin 25 mg QD for 5 days Receives: Drug: Empagliflozin 25mg; Drug: Lobeglitazone 0.5mg; Drug: Empagliflozin 25mg/Lobeglitazone 0.5mg
Empa.+Lobe. / Empagliflozin / Lobeglitazone	Experimental	Period 1: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Period 2: Empagliflozin 25 mg QD for 5 days Period 3: Lobeglitazone 0.5 mg QD for 5 days Receives: Drug: Empagliflozin 25mg; Drug: Lobeglitazone 0.5mg; Drug: Empagliflozin 25mg/Lobeglitazone 0.5mg
Empa.+Lobe. / Lobeglitazone / Empagliflozin	Experimental	Period 1: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Period 2: Lobeglitazone 0.5 mg QD for 5 days Period 3: Empagliflozin 25 mg QD for 5 days Receives: Drug: Empagliflozin 25mg; Drug: Lobeglitazone 0.5mg; Drug: Empagliflozin 25mg/Lobeglitazone 0.5mg

What is being measured

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

AUC0-t,ss of Empagliflozin
Measured: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours
Cmax,ss of Empagliflozin
Measured: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours
AUC0-t,ss of Lobeglitazone
Measured: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours
Cmax,ss of Lobeglitazone
Measured: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours

Secondary outcomes (6)

Tmax,ss of Empagliflozin
Measured: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours
t1/2,ss of Empagliflozin
Measured: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours
AUCinf of Empagliflozin
Measured: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours
Tmax,ss of Lobeglitazone
Measured: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours
t1/2,ss of Lobeglitazone
Measured: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours
AUCinf of Lobeglitazone
Measured: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours

Timeline

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

Aug 2016Sep 2016

First posted3 Aug 2016 (estimated)
Study startAug 2016
Primary completionSep 2016 (estimated)
Study completionSep 2016 (estimated)

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 IIStudies 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: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02854748
Sponsor's protocol ID: 19DDI16005
Status last verified: Aug 2016
First submitted: 1 Aug 2016
Last updated: 9 Aug 2016
Results posted: No

Publications

Kim YK, Hwang JG, Park MK. No Relevant Pharmacokinetic Drug-Drug Interaction Between the Sodium-Glucose Co-Transporter-2 Inhibitor Empagliflozin and Lobeglitazone, a Peroxisome Proliferator-Activated Receptor-gamma Agonist, in Healthy Subjects. Drug Des Devel Ther. 2021 Apr 28;15:1725-1734. doi: 10.2147/DDDT.S302215. eCollection 2021.
PubMed 33953542

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Multiple Dosing, Crossover Study to Evaluate the Drug-drugs Interaction Between Lobeglitazone and Empagliflozin in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT02854748
Acronym / sponsor ID: 19DDI16005
Conditions: Diabetes Mellitus, Type II
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 30 participants (estimated)
Lead sponsor: Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
Study start: Aug 2016
Primary completion: Sep 2016 (estimated)
Study completion: Sep 2016 (estimated)
First posted: 3 Aug 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.

This study is a randomized, open-label, multiple dosing, crossover study to evaluate the drug-drugs interaction between Lobeglitazone and Empagliflozin in healthy male volunteers

Detailed description

To healthy male subjects of 30, following treatments are administered dosing in each 3 period(Lobeglitazone or Empagliflozin or Lobe.+Empa.) and wash-out period is a minimum of 7 days.

Test Drug 1: Lobeglitazone 0.5mg 1T

Test Drug 2: Empagliflozin 25mg 1T

Pharmacokinetic blood samples are collected up to 24hrs.

Safety, pharmacokinetic and the drug-drugs interaction are assessed.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Empagliflozin / Lobeglitazone / Empa.+Lobe.	Experimental	Drug: Empagliflozin 25mg, Drug: Lobeglitazone 0.5mg, Drug: Empagliflozin 25mg/Lobeglitazone 0.5mgPeriod 1: Empagliflozin 25 mg QD for 5 days Period 2: Lobeglitazone 0.5 mg QD for 5 days Period 3: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days
Empagliflozin / Empa.+Lobe. / Lobeglitazone	Experimental	Drug: Empagliflozin 25mg, Drug: Lobeglitazone 0.5mg, Drug: Empagliflozin 25mg/Lobeglitazone 0.5mgPeriod 1: Empagliflozin 25 mg QD for 5 days Period 2: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Period 3: Lobeglitazone 0.5 mg QD for 5 days
Lobeglitazone / Empagliflozin / Empa.+Lobe.	Experimental	Drug: Empagliflozin 25mg, Drug: Lobeglitazone 0.5mg, Drug: Empagliflozin 25mg/Lobeglitazone 0.5mgPeriod 1: Lobeglitazone 0.5 mg QD for 5 days Period 2: Empagliflozin 25 mg QD for 5 days Period 3: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days
Lobeglitazone / Empa.+Lobe. / Empagliflozin	Experimental	Drug: Empagliflozin 25mg, Drug: Lobeglitazone 0.5mg, Drug: Empagliflozin 25mg/Lobeglitazone 0.5mgPeriod 1: Lobeglitazone 0.5 mg QD for 5 days Period 2: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Period 3: Empagliflozin 25 mg QD for 5 days
Empa.+Lobe. / Empagliflozin / Lobeglitazone	Experimental	Drug: Empagliflozin 25mg, Drug: Lobeglitazone 0.5mg, Drug: Empagliflozin 25mg/Lobeglitazone 0.5mgPeriod 1: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Period 2: Empagliflozin 25 mg QD for 5 days Period 3: Lobeglitazone 0.5 mg QD for 5 days
Empa.+Lobe. / Lobeglitazone / Empagliflozin	Experimental	Drug: Empagliflozin 25mg, Drug: Lobeglitazone 0.5mg, Drug: Empagliflozin 25mg/Lobeglitazone 0.5mgPeriod 1: Empagliflozin 25 mg + Lobeglitazone 0.5 mg QD for 5 days Period 2: Lobeglitazone 0.5 mg QD for 5 days Period 3: Empagliflozin 25 mg QD for 5 days

Who may qualify

Ages: 19 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

A healthy person whose age is in between 19 to 45 during the screening tests
Whose weight is more than 55 kg, BMI is over 18.5 and under 29.9 during the screening test. (BMI (kg/m2) = 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 tests
The participants must have an ability and willingness to participate throughout the entire trials

Key exclusion criteria (19 listed)

A person who has a history of clinically significant cardiovascular, respiratory, liver, kidney, endocrine system, immune system, urinary system diseases, blood-tumor diseases, mental illness.
Who had a history 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 has a history of hypersensitivity reactions to Empagliflozin or Lobeglitazone or similar series or other excipient ingredients (aspirin, fibrate, antibiotics, etc.)
A person whose electrocardiogram value includes QTc > 450 msec, PR interval > 200 msec, QRS duration > 120 msec after screening, or who show clinically significant opinion.
Who falls under the following results

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
Empagliflozin 25mgEmpagliflozin 25 mg QD for 5 days	Drug	Empa.+Lobe. / Empagliflozin / Lobeglitazone, Empa.+Lobe. / Lobeglitazone / Empagliflozin, Empagliflozin / Empa.+Lobe. / Lobeglitazone, Empagliflozin / Lobeglitazone / Empa.+Lobe., Lobeglitazone / Empa.+Lobe. / Empagliflozin, Lobeglitazone / Empagliflozin / Empa.+Lobe.
Lobeglitazone 0.5mgLobeglitazone 0.5mg QD for 5 days	Drug	Empa.+Lobe. / Empagliflozin / Lobeglitazone, Empa.+Lobe. / Lobeglitazone / Empagliflozin, Empagliflozin / Empa.+Lobe. / Lobeglitazone, Empagliflozin / Lobeglitazone / Empa.+Lobe., Lobeglitazone / Empa.+Lobe. / Empagliflozin, Lobeglitazone / Empagliflozin / Empa.+Lobe.
Empagliflozin 25mg/Lobeglitazone 0.5mgEmpagliflozin 25 mg + Lobeglitazone 0.5mg QD for 5 days	Drug	Empa.+Lobe. / Empagliflozin / Lobeglitazone, Empa.+Lobe. / Lobeglitazone / Empagliflozin, Empagliflozin / Empa.+Lobe. / Lobeglitazone, Empagliflozin / Lobeglitazone / Empa.+Lobe., Lobeglitazone / Empa.+Lobe. / Empagliflozin, Lobeglitazone / Empagliflozin / Empa.+Lobe.

Primary outcome

AUC0-t,ss of Empagliflozin
Time frame: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours
Cmax,ss of Empagliflozin
Time frame: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours
AUC0-t,ss of Lobeglitazone
Time frame: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours
Cmax,ss of Lobeglitazone
Time frame: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours

6 secondary outcomes

Tmax,ss of Empagliflozin
Time frame: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours
t1/2,ss of Empagliflozin
Time frame: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours
AUCinf of Empagliflozin
Time frame: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours
Tmax,ss of Lobeglitazone
Time frame: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours
t1/2,ss of Lobeglitazone
Time frame: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours
AUCinf of Lobeglitazone
Time frame: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
Derived from this study: PubMed 33953542Kim YK, Hwang JG, Park MK. No Relevant Pharmacokinetic Drug-Drug Interaction Between the Sodium-Glucose Co-Transporter-2 Inhibitor Empagliflozin and Lobeglitazone, a Peroxisome Proliferator-Activated Receptor-gamma Agonist, in Healthy Subjects. Drug Des Devel Ther. 2021 Apr 28;15:1725-1734. doi: 10.2147/DDDT.S302215. eCollection 2021.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 9 Aug 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?

Results are not available in the source record.

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?

AUC0-t,ss of Empagliflozin (time frame: Day 1, 2, 3, 4 (Day 12 - 15, Day 23 - 26): 0 hour, Day 5 (Day 16, Day 27): 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 hours). The study lists 4 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 NCT02854748, 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 2016.