Type 2 Diabetes MellitusPhase 1NCT02167061

A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01 Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 in Healthy Male Volunteers

A Phase 1 study testing DA-1229_01, E+M and DA-1229_01 fast in people with Type 2 Diabetes Mellitus, 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

This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01 and to investigate the effect of food on the pharmacokinetics of DA-1229_01 in healthy male volunteers Read more about this study

Who is it for?: Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: DA-1229_01, E+M and DA-1229_01 fast
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteSouth Korea
Study dates: Jul 2014to Nov 2014
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 20 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Age between 20 to 45, healthy male subjects(at screening)
Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
FPG 60-125mg/dL glucose level(at screening)
Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Who cannot join

Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction
Subject who already participated in other trials in 2 months
Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Clinical Trial Center, Seoul National University Hospital
Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Crossover, Single Dose Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 5/1000 mg) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 After Single Oral Administration in Healthy Male Volunteers

Conditions: Type 2 Diabetes Mellitus
Being tested: DA-1229_01, E+M, DA-1229_01 fast, DA-1229_01 fed
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.

DA-1229_01Drug
Also called Evogliptin/Metformin XR 5/1000 mg
complex single administration
E+MDrug
Also called Evogliptin 5 mg + Metformin XR 1000 mg
co-administration of 2 drugs
DA-1229_01 fastDrug
DA-1229_01 fedDrug

Study groups in NCT02167061
Study group	Role	What they receive
(Part 1) DA-1229_01 → E+M	Experimental	DA-1229_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg Receives: Drug: DA-1229_01; Drug: E+M
(Part 1) E+M → DA-1229_01	Experimental	DA-1229_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg Receives: Drug: DA-1229_01; Drug: E+M
(Part 2) DA-1229_01 fast → fed	Experimental	DA-1229_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet Receives: Drug: DA-1229_01 fast; Drug: DA-1229_01 fed
DA-1229_01 fed → fast	Experimental	DA-1229_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet Receives: Drug: DA-1229_01 fast; Drug: DA-1229_01 fed

What is being measured

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

Area Under Curve(AUC)last of Evogliptin and Metformin
Measured: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Maximum of concentration (Cmax) of Evogliptin and Metformin
Measured: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose

Secondary outcomes (5)

Time of maximum concentration(Tmax) of Evogliptin and Metformin
Measured: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Terminal half-life(t1/2) of Evogliptin and Metformin
Measured: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Apparent Clearance(CL/F) of Evogliptin and Metformin
Measured: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Area Under Curve(AUC)inf of Evogliptin and Metformin
AUCinf = AUC last + Clast/λz
Measured: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Time prior to the first measurable concentration (tlag) of Metformin (only in Part 2 trial)
Measured: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose

Timeline

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

Jul 2014Nov 2014

First posted18 Jun 2014 (estimated)
Study startJul 2014
Primary completionNov 2014
Study completionNov 2014

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: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02167061
Sponsor's protocol ID: DA1229_01_BE_I
Status last verified: Nov 2014
First submitted: 11 Jun 2014
Last updated: 2 Dec 2014
Results posted: No
Data monitoring committee: Yes

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 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Crossover, Single Dose Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 5/1000 mg) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 After Single Oral Administration in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT02167061
Acronym / sponsor ID: DA1229_01_BE_I
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 18 Jun 2014 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
(Part 1) DA-1229_01 → E+M	Experimental	Drug: DA-1229_01, Drug: E+MDA-1229_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg
(Part 1) E+M → DA-1229_01	Experimental	Drug: DA-1229_01, Drug: E+MDA-1229_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg
(Part 2) DA-1229_01 fast → fed	Experimental	Drug: DA-1229_01 fast, Drug: DA-1229_01 fedDA-1229_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet
DA-1229_01 fed → fast	Experimental	Drug: DA-1229_01 fast, Drug: DA-1229_01 fedDA-1229_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet

Who may qualify

Ages: 20 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Age between 20 to 45, healthy male subjects(at screening)
Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
FPG 60-125mg/dL glucose level(at screening)
Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Key exclusion criteria (5 listed)

Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction
Subject who already participated in other trials in 2 months
Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion

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
DA-1229_01Also: Evogliptin/Metformin XR 5/1000 mgcomplex single administration	Drug	(Part 1) DA-1229_01 → E+M, (Part 1) E+M → DA-1229_01
E+MAlso: Evogliptin 5 mg + Metformin XR 1000 mgco-administration of 2 drugs	Drug	(Part 1) DA-1229_01 → E+M, (Part 1) E+M → DA-1229_01
DA-1229_01 fast	Drug	(Part 2) DA-1229_01 fast → fed, DA-1229_01 fed → fast
DA-1229_01 fed	Drug	(Part 2) DA-1229_01 fast → fed, DA-1229_01 fed → fast

Primary outcome

Area Under Curve(AUC)last of Evogliptin and Metformin
Time frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Maximum of concentration (Cmax) of Evogliptin and Metformin
Time frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose

5 secondary outcomes

Time of maximum concentration(Tmax) of Evogliptin and Metformin
Time frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Terminal half-life(t1/2) of Evogliptin and Metformin
Time frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Apparent Clearance(CL/F) of Evogliptin and Metformin
Time frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Area Under Curve(AUC)inf of Evogliptin and Metformin
Time frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Time prior to the first measurable concentration (tlag) of Metformin (only in Part 2 trial)
Time frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose

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 2 Dec 2014.

Related trials for Type 2 Diabetes Mellitus

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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.

Kyung-sang Yu, Ph.d., M.B.A principal investigator

Seoul National University Hospital

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 DA-1229_01, E+M and DA-1229_01 fast in people with Type 2 Diabetes Mellitus, 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 4 inclusion and 5 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 2 Dec 2014. 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?

Area Under Curve(AUC)last of Evogliptin and Metformin (time frame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose). 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 NCT02167061.

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 2 Dec 2014.