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AzTrials

Type2 DiabetesPhase 1NCT02954822

Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5mg and Glimepiride 4mg

A Phase 1 study testing Evogliptin→Evogliptin+Glimepiride→Glimepiride and Glimepiride→Evogliptin→Evogliptin+Glimepiride 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 dosing, three treatment, three period, two sequence clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and glimepiride 4 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
Type2 Diabetes
What is being tested?
Evogliptin→Evogliptin+Glimepiride→Glimepiride and Glimepiride→Evogliptin→Evogliptin+Glimepiride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteSouth Korea
Study dates
14 Nov 2016to 9 Aug 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, Cross-over Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5mg and Glimepiride 4mg After Oral Administration in Healthy Male Subjects

A randomized, open-label, multiple dosing, three treatment, three period, two sequence clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and glimepiride 4 mg after oral administration in healthy male subjects

Read the detailed description

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

Conditions
Type2 Diabetes
Being tested
Evogliptin→Evogliptin+Glimepiride→Glimepiride, Glimepiride→Evogliptin→Evogliptin+Glimepiride

What participants receive

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

  • Evogliptin→Evogliptin+Glimepiride→GlimepirideDrug

    Also called Suganon, Amaryl

    Evogliptin 5mg will be administered for 7days and then glimepiride 4mg will be added on and administered with Evogliptin 5mg for 2 days. After the washout period for 10 days, Glimepiride 4mg will be administered for 2 days.

    Glimepiride : Glimepiride 4mg QD

    Evogliptin + Glimepiride : Evogliptin 5mg QD + Glimepiride 4mg QD

  • Glimepiride→Evogliptin→Evogliptin+GlimepirideDrug

    Also called Suganon, Amaryl

    After 2 days of administration of Glimepiride 4mg follows the 10-day washout period. Afterwards Evogliptin 5mg will be administered for 7days and then glimepiride 4mg will be added on and administered with Evogliptin 5mg for 2 days.

Study groups in NCT02954822
Study groupRoleWhat they receive
(Group A)ExperimentalEvogliptin→Evogliptin+Glimepiride→Glimepiride
Receives: Drug: Evogliptin→Evogliptin+Glimepiride→Glimepiride
(Group B)ExperimentalGlimepiride→Evogliptin→Evogliptin+Glimepiride
Receives: Drug: Glimepiride→Evogliptin→Evogliptin+Glimepiride

What is being measured

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

  1. AUCτ,ss for Evogliptin and Glimepiride

    area under the concentration-time curve

    Measured: 3 weeks

Timeline

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

  1. First posted3 Nov 2016 (estimated)
  2. Study start14 Nov 2016
  3. Primary completion25 Jan 2017
  4. Study completion9 Aug 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
NCT02954822
Sponsor's protocol ID
DA1229_DIG_I
Status last verified
Sep 2017
First submitted
2 Nov 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→Evogliptin+Glimepiride→Glimepiride and Glimepiride→Evogliptin→Evogliptin+Glimepiride 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 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?

AUCτ,ss for Evogliptin and Glimepiride (time frame: 3 weeks). 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 NCT02954822.

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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