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Type 2 DiabetesPhase 1NCT02753803

Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5 mg and Pioglitazone 30 mg

A Phase 1 study testing Evogliptin, Pioglitazone, Evogliptin+Pioglitazone, Pioglitazone, Evogliptin, Evogliptin+Pioglitazone and Evogliptin, Evogliptin+Pioglitazone, Pioglitazone in people with Type 2 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 dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and pioglitazone 30 mg after oral administration in healthy male subjects 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
Type 2 Diabetes
What is being tested?
Evogliptin, Pioglitazone, Evogliptin+Pioglitazone, Pioglitazone, Evogliptin, Evogliptin+Pioglitazone and Evogliptin, Evogliptin+Pioglitazone, Pioglitazone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteSouth Korea
Study dates
27 Jul 2016to 10 Mar 2017
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

  • Healthy Male Volunteers (Age: 19~45years)
  • 55<Body Weight<90, 18<BMI<27
  • FPG: 70-125 mg/dL

Who cannot join

  • galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  • Clinically significant Medical History
  • Allergy or Drug Hypersensitivity
  • AST(SGOT), ALT(SGPT) > Upper Normal Range*1.5, eGFR<80 mL/min
  • 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, Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5 mg and Pioglitazone 30 mg

A randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and pioglitazone 30 mg after oral administration in healthy male subjects

Read the detailed description

A randomized, open-label, multiple-dose, three-treatment, three-period, six-sequence, crossover study

Conditions
Type 2 Diabetes
Being tested
Evogliptin, Pioglitazone, Evogliptin+Pioglitazone, Pioglitazone, Evogliptin, Evogliptin+Pioglitazone, Evogliptin, Evogliptin+Pioglitazone, Pioglitazone, Pioglitazone, Evogliptin+Pioglitazone, Evogliptin, Evogliptin+Pioglitazone, Evogliptin, Pioglitazone
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.

  • Evogliptin, Pioglitazone, Evogliptin+PioglitazoneDrug

    Also called Suganon, Actos

    Evogliptin : Evogliptin 5mg QD Pioglitazone : Pioglitazone 30mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD

  • Pioglitazone, Evogliptin, Evogliptin+PioglitazoneDrug

    Also called Suganon, Actos

    Pioglitazone : Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD

  • Evogliptin, Evogliptin+Pioglitazone, PioglitazoneDrug

    Also called Suganon, Actos

    Evogliptin : Evogliptin 5mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Pioglitazone : Pioglitazone 30mg QD

  • Pioglitazone, Evogliptin+Pioglitazone, EvogliptinDrug

    Also called Suganon, Actos

    Pioglitazone : Pioglitazone 30mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD

  • Evogliptin+Pioglitazone, Evogliptin, PioglitazoneDrug

    Also called Suganon, Actos

    Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD Pioglitazone : Pioglitazone 30mg QD

  • Evogliptin+Pioglitazone, Pioglitazone, EvogliptinDrug

    Also called Suganon, Actos

    Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Pioglitazone : Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD

Study groups in NCT02753803
Study groupRoleWhat they receive
A groupExperimentalEvogliptin Pioglitazone Evogliptin+Pioglitazone
Receives: Drug: Evogliptin, Pioglitazone, Evogliptin+Pioglitazone
B groupExperimentalPioglitazone Evogliptin Evogliptin+Pioglitazone
Receives: Drug: Pioglitazone, Evogliptin, Evogliptin+Pioglitazone
C groupExperimentalEvogliptin Evogliptin+Pioglitazone Pioglitazone
Receives: Drug: Evogliptin, Evogliptin+Pioglitazone, Pioglitazone
D groupExperimentalPioglitazone Evogliptin+Pioglitazone Evogliptin
Receives: Drug: Pioglitazone, Evogliptin+Pioglitazone, Evogliptin
E groupExperimentalEvogliptin+Pioglitazone Evogliptin Pioglitazone
Receives: Drug: Evogliptin+Pioglitazone, Evogliptin, Pioglitazone
F groupExperimentalEvogliptin+Pioglitazone Pioglitazone Evogliptin
Receives: Drug: Evogliptin+Pioglitazone, Pioglitazone, Evogliptin

What is being measured

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

  1. AUC

    area under the concentration-time curve

    Measured: 1d~6d pre-dose, 15d~20d pre-dose, 29~34d pre-dose, 7d/21d/35d pre-dose and post-dose

Timeline

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

  1. First posted28 Apr 2016 (estimated)
  2. Study start27 Jul 2016
  3. Primary completion19 Oct 2016
  4. Study completion10 Mar 2017

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
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02753803
Sponsor's protocol ID
DA1229_DIP_I
Status last verified
Sep 2017
First submitted
25 Apr 2016
Last updated
18 Sep 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Evogliptin, Pioglitazone, Evogliptin+Pioglitazone, Pioglitazone, Evogliptin, Evogliptin+Pioglitazone and Evogliptin, Evogliptin+Pioglitazone, Pioglitazone in people with Type 2 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 3 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 18 Sep 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?

AUC (time frame: 1d~6d pre-dose, 15d~20d pre-dose, 29~34d pre-dose, 7d/21d/35d pre-dose and post-dose). 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 NCT02753803.

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 18 Sep 2017.

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