Diabetes Mellitus, Type 2Phase 4NCT02587975
Effect of Evogliptin on Bone Metabolism in Human
A Phase 4 study testing Evogliptin in people with Diabetes Mellitus, Type 2 and Osteoporosis, run by DongGuk University at 1 site in South Korea.
Trial summary
This study is designed to measure the effect of evogliptin on bone metabolism in healthy volunteers. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Osteoporosis
- What is being tested?
- Evogliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2016to Mar 2017
- Phase
- Phase 4
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal healthy women (at least 5 years)
- BMI 18~30 kg/m2
Who cannot join
- Presence or history of hypersensitivity or allergic reactions to any drug
- Clinically relevant abnormal medical history or present disease
- Presence or history of drug abuse
- Participation in other clinical trial within 2 months before dose.
- Bood donation during 2 months or apheresis during 1 month before the study.
- Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before dose.
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- Use of any drug which can affect bone metabolism such as sex hormones or their receptor related medicine, calcitonin or parathyroid hormone related medicine, systemic corticosteroid, bisphosphate, or etc.
- Smoking of more than 10 cigarettes/days within 3 months before first dose.
- Use of alcohol over 21 units/weeks
- Subject judged not eligible for study participation by investigator.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 410-773
Namyi Gu, MD, PhD, +82-31-961-8440, namyi.gu@gmail.com
About this study
Official title: Pharmacodynamics Study to Investigate the Effect of Evogliptin on Bone Metabolism in Healthy Volunteers
This study is designed to measure the effect of evogliptin on bone metabolism in healthy volunteers.
- Conditions
- Diabetes Mellitus, Type 2, Osteoporosis
- Being tested
- Evogliptin
- Medical subject headings
- Diabetes Mellitus, Type 2, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvogliptinDrug
Also called DA-1229, Suganon
10 mg
| Study group | Role | What they receive |
|---|---|---|
| Evogliptin 10 mg | Experimental | Single oral administration of 2 tablets of evogliptin 5 mg with water 250 mL Receives: Drug: Evogliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of C-terminal telopeptide after treatment in comparison with the baseline
Measured: Predose and 1, 2, 3, 4, 6, 14, 20, 24 h postdose on Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startJun 2016
- Primary completionNov 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DongGuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Namyi Gu, DongGuk University
- Investigators
- Namyi Gu, MD, PhD, Principal investigator, Dongguk University College of Medicine and Ilsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587975
- Sponsor's protocol ID
- DUMC-EVOG-BONE
- Status last verified
- Jul 2016
- First submitted
- 26 Oct 2015
- Last updated
- 25 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamics Study to Investigate the Effect of Evogliptin on Bone Metabolism in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02587975
- Acronym / sponsor ID
- DUMC-EVOG-BONE
- Conditions
- Diabetes Mellitus, Type 2, Osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- DongGuk UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 27 Oct 2015 (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.
This study is designed to measure the effect of evogliptin on bone metabolism in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evogliptin 10 mg | Experimental | Drug: EvogliptinSingle oral administration of 2 tablets of evogliptin 5 mg with water 250 mL |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal healthy women (at least 5 years)
- BMI 18~30 kg/m2
Key exclusion criteria (10 listed)
- Presence or history of hypersensitivity or allergic reactions to any drug
- Clinically relevant abnormal medical history or present disease
- Presence or history of drug abuse
- Participation in other clinical trial within 2 months before dose.
- Bood donation during 2 months or apheresis during 1 month before 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 |
|---|---|---|
| EvogliptinAlso: DA-1229, Suganon10 mg | Drug | Evogliptin 10 mg |
Primary outcome
Serum concentration of C-terminal telopeptide after treatment in comparison with the baseline
Time frame: Predose and 1, 2, 3, 4, 6, 14, 20, 24 h postdose on Day 1 and Day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
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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.
Namyi Gu, MD, PhD principal investigator
Dongguk University College of Medicine and Ilsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Evogliptin in people with Diabetes Mellitus, Type 2 and Osteoporosis, run by DongGuk University 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 10 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: status not confirmed, as of the sponsor's last update on 25 Jul 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Namyi Gu, MD, PhD (+82-31-961-8440, namyi.gu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentration of C-terminal telopeptide after treatment in comparison with the baseline (time frame: Predose and 1, 2, 3, 4, 6, 14, 20, 24 h postdose on Day 1 and Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2016.