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AzTrials

Type2 DiabetesPhase 1NCT03766724

Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin and Empagliflozin or Dapagliflozin in Healthy Male Adults

A Phase 1 study testing Evogliptin→Evogliptin+Empagliflozin→Empagliflozin, Empagliflozin→Evogliptin→Evogliptin+Empagliflozin and Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin in people with Type2 Diabetes, run by Dong-A ST Co., Ltd. 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

A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or Dapagliflozin 10 mg after Oral Administration in Healthy Male Adults Read more about this study

Who is it for?
Ages 19 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Type2 Diabetes
What is being tested?
Evogliptin→Evogliptin+Empagliflozin→Empagliflozin, Empagliflozin→Evogliptin→Evogliptin+Empagliflozin and Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteSouth Korea
Study dates
22 Nov 2018to 18 Jan 2019
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 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Health Male Volunteers (Age : 19~55 years)
  • Body Weight≥55kg, 18.5≤BMI<25.0

Who cannot join

  • galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  • Allergy or Drug hypersensitivity
  • Clinically significant Medical History
  • AST, ALT > Upper Normal Range*1.25, eGFR<60mL/min/1.73㎡
  • Drink during clinical trial period
  • Smoking during clinical trial period
  • Grapefruit/Caffeine intake during clinical trial period
  • No Contraception

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Clinical Trials Center, Severance Hospital

    Seoul, 03722

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or Dapagliflozin 10 mg After Oral Administration in Healthy Male Adults

A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or Dapagliflozin 10 mg after Oral Administration in Healthy Male Adults

Conditions
Type2 Diabetes
Being tested
Evogliptin→Evogliptin+Empagliflozin→Empagliflozin, Empagliflozin→Evogliptin→Evogliptin+Empagliflozin, Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin, Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin

What participants receive

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

  • Evogliptin→Evogliptin+Empagliflozin→EmpagliflozinDrug

    Also called Suganon, Jardiance

    Evogliptin : Evogliptin 5mg QD, Evogliptin+Empagliflozin : Evogliptin 5mg QD + Empagliflozin 25mg QD, Empagliflozin : Empagliflozin 25mg QD

  • Empagliflozin→Evogliptin→Evogliptin+EmpagliflozinDrug

    Also called Suganon, Jardiance

    Empagliflozin : Empagliflozin 25mg QD, Evogliptin : Evogliptin 5mg QD, Evogliptin+Empagliflozin : Evogliptin 5mg QD + Empagliflozin 25mg QD

  • Evogliptin→Evogliptin+Dapagliflozin→DapagliflozinDrug

    Also called Suganon, Forxiga

    Evogliptin : Evogliptin 5mg QD, Evogliptin+Dapagliflozin : Evogliptin 5mg QD + Dapagliflozin 10mg QD, Dapagliflozin : Dapagliflozin 10mg QD

  • Dapagliflozin→Evogliptin→Evogliptin+DapagliflozinDrug

    Also called Suganon, Forxiga

    Dapagliflozin : Dapagliflozin 10mg QD, Evogliptin : Evogliptin 5mg QD, Evogliptin+Dapagliflozin : Evogliptin 5mg QD + Dapagliflozin 10mg QD

Study groups in NCT03766724
Study groupRoleWhat they receive
Group AExperimentalEvogliptin→Evogliptin+Empagliflozin→Empagliflozin
Receives: Drug: Evogliptin→Evogliptin+Empagliflozin→Empagliflozin
Group BExperimentalEmpagliflozin→Evogliptin→Evogliptin+Empagliflozin
Receives: Drug: Empagliflozin→Evogliptin→Evogliptin+Empagliflozin
Group CExperimentalEvogliptin→Evogliptin+Dapagliflozin→Dapagliflozin
Receives: Drug: Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin
Group DExperimentalDapagliflozin→Evogliptin→Evogliptin+Dapagliflozin
Receives: Drug: Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin

What is being measured

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

  1. AUCτ,ss

    area under the concentration-time curve

    Measured: 4 weeks

  2. Cmax,ss

    maximum serum concentration

    Measured: 4 weeks

Timeline

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

  1. First posted6 Dec 2018
  2. Study start22 Nov 2018
  3. Primary completion18 Jan 2019
  4. Study completion18 Jan 2019

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
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03766724
Sponsor's protocol ID
DA1229_DIS_I
Status last verified
Apr 2019
First submitted
5 Dec 2018
Last updated
10 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Evogliptin→Evogliptin+Empagliflozin→Empagliflozin, Empagliflozin→Evogliptin→Evogliptin+Empagliflozin and Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin in people with Type2 Diabetes, run by Dong-A ST Co., Ltd. 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 2 inclusion and 8 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 10 Apr 2019. 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,ss (time frame: 4 weeks). 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 NCT03766724.

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 10 Apr 2019.

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