Type 2 Diabetes MellitusPhase 1NCT04431141

Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin

A Phase 1 study testing Teneligliptin, Empagliflozin and Teneligliptin and Empagliflozin in people with Type 2 Diabetes Mellitus, run by Handok Inc. 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

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Trial summary

This study is to evaluate pharmacokinetic drug interaction between teneligliptin and empagliflozin in healthy adults. Read more about this study

Who is it for?: Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Teneligliptin, Empagliflozin and Teneligliptin and Empagliflozin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteSouth Korea
Study dates: 15 Sep 2020to 25 Jan 2021
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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adults between 19 and 45 years of age (both inclusive) at the screening visit
Body mass index between 19 kg/m2 and 28 kg/m2 (both inclusive) at the screening visit
Subjects must voluntarily decide to participate in the study and provide written informed consent to comply with study instructions

Who cannot join

History of type 1 diabetes mellitus and/or diabetic ketoacidosis
Severe infection, surgery, or severe trauma within 6 months prior to the screening visit
Hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Treatment with any investigational product or study drug in another clinical trial or bioequivalence study within 180 days prior to the screening visit
Any laboratory test or 12-lead ECG finding based on which the subject is determined ineligible to participate in the study
Subject determined by the principal investigator to be ineligible for study conduct for other reasons

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Clinical Pharmacology, Asan Medical Center
Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Multiple-dose, Cross-over Dosing Study to Evaluate Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin in Healthy Adults

This study is to evaluate pharmacokinetic drug interaction between teneligliptin and empagliflozin in healthy adults.

Conditions: Type 2 Diabetes Mellitus
Being tested: Teneligliptin, Empagliflozin, Teneligliptin and Empagliflozin
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.

TeneligliptinDrug
Also called Tenelia®
Teneligliptin alone
EmpagliflozinDrug
Also called Jardiance®
Empagliflozin alone
Teneligliptin and EmpagliflozinDrug
Also called Tenelia® and Jardiance®
Teneligliptin and empagliflozin

Study groups in NCT04431141
Study group	Role	What they receive
Teneligliptin	Experimental	Not described Receives: Drug: Teneligliptin
Empagliflozin	Experimental	Not described Receives: Drug: Empagliflozin
Teneligliptin and Empagliflozin	Experimental	Not described Receives: Drug: Teneligliptin and Empagliflozin

What is being measured

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

Cmax,ss of teneligliptin and empagliflozin
Peak Plasma Concentration (Cmax) at steady state
Measured: 72 hours
AUCτ,ss of teneligliptin and empagliflozin
Area under the plasma concentration versus time curve (AUC) at steady state
Measured: 72 hours

Secondary outcomes (2)

Tmax,ss of teneligliptin and empagliflozin
Time to reach Cmax,ss
Measured: 72 hours
t1/2β of teneligliptin and empagliflozin
Terminal elimination half-life
Measured: 72 hours

Timeline

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

15 Sep 202025 Jan 2021

First posted16 Jun 2020
Study start15 Sep 2020
Primary completion16 Nov 2020
Study completion25 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
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: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04431141
Sponsor's protocol ID: MP-C105
Status last verified: Nov 2021
First submitted: 4 Jun 2020
Last updated: 15 Nov 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Multiple-dose, Cross-over Dosing Study to Evaluate Pharmacokinetic Drug Interaction Between Teneligliptin and Empagliflozin in Healthy Adults
ClinicalTrials.gov ID: NCT04431141
Acronym / sponsor ID: MP-C105
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Handok Inc.Industry (pharma, biotech, devices)
Study start: 15 Sep 2020 (actual)
Primary completion: 16 Nov 2020 (actual)
Study completion: 25 Jan 2021 (actual)
First posted: 16 Jun 2020 (actual)
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 to evaluate pharmacokinetic drug interaction between teneligliptin and empagliflozin in healthy adults.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Teneligliptin	Experimental	Drug: Teneligliptin
Empagliflozin	Experimental	Drug: Empagliflozin
Teneligliptin and Empagliflozin	Experimental	Drug: Teneligliptin and Empagliflozin

Who may qualify

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

Key inclusion criteria (3 listed)

Healthy adults between 19 and 45 years of age (both inclusive) at the screening visit
Body mass index between 19 kg/m2 and 28 kg/m2 (both inclusive) at the screening visit
Subjects must voluntarily decide to participate in the study and provide written informed consent to comply with study instructions

Key exclusion criteria (6 listed)

History of type 1 diabetes mellitus and/or diabetic ketoacidosis
Severe infection, surgery, or severe trauma within 6 months prior to the screening visit
Hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Treatment with any investigational product or study drug in another clinical trial or bioequivalence study within 180 days prior to the screening visit
Any laboratory test or 12-lead ECG finding based on which the subject is determined ineligible to participate in the study

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
TeneligliptinAlso: Tenelia®Teneligliptin alone	Drug	Teneligliptin
EmpagliflozinAlso: Jardiance®Empagliflozin alone	Drug	Empagliflozin
Teneligliptin and EmpagliflozinAlso: Tenelia® and Jardiance®Teneligliptin and empagliflozin	Drug	Teneligliptin and Empagliflozin

Primary outcome

Cmax,ss of teneligliptin and empagliflozin
Time frame: 72 hours
Peak Plasma Concentration (Cmax) at steady state
AUCτ,ss of teneligliptin and empagliflozin
Time frame: 72 hours
Area under the plasma concentration versus time curve (AUC) at steady state

2 secondary outcomes

Tmax,ss of teneligliptin and empagliflozin
Time frame: 72 hours
t1/2β of teneligliptin and empagliflozin
Time frame: 72 hours

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 15 Nov 2021.
Individual participant dataSharing planned: No

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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?

A Phase 1 study testing Teneligliptin, Empagliflozin and Teneligliptin and Empagliflozin in people with Type 2 Diabetes Mellitus, run by Handok Inc. 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 3 inclusion and 6 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 15 Nov 2021. 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?

Cmax,ss of teneligliptin and empagliflozin (time frame: 72 hours). 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 NCT04431141.

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 15 Nov 2021.