Type2 DiabetesPhase 1NCT03939143
A Study to Investigate the Bioequivalence Test of DA-1229_01(A) at Fasting State
A Phase 1 study testing DA-1229_01(A), Sugamet SR Tab 5/1000mg® and Sugamet SR Tab 5/1000mg®, DA-1229_01(A) in people with Type2 Diabetes, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
A study demonstrates the bioequivalence of DA-1229_01(A) at Fasting State when compared with Sugamet sustained-release(SR) Tab 5/1000mg® in healthy adults Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- DA-1229_01(A), Sugamet SR Tab 5/1000mg® and Sugamet SR Tab 5/1000mg®, DA-1229_01(A)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Feb 2019to 4 Apr 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients over 19 years of age at the time of health examination
- Female patients who were confirmed to be not pregnant at health examination
- Patients without a history of mental illness in the past 5 years
Who cannot join
- Patients who have taken medications which could affect the results of the clinical trial in the past 10 days of participating in the clinical trial
- Patients with a congestive heart failure which requires medicinal treatment
- Patients who have made a whole blood donation in the past 2 months or an apheresis donation in the past 2 weeks of participating in the clinical trial
- Female patients who are lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Open Label, Single Oral Administration at Fasting State, 2 x 2 Crossover Study to Investigate the Bioequivalence Test of DA-1229_01(A)
A study demonstrates the bioequivalence of DA-1229_01(A) at Fasting State when compared with Sugamet sustained-release(SR) Tab 5/1000mg® in healthy adults
- Conditions
- Type2 Diabetes
- Being tested
- DA-1229_01(A), Sugamet SR Tab 5/1000mg®, Sugamet SR Tab 5/1000mg®, DA-1229_01(A)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-1229_01(A), Sugamet SR Tab 5/1000mg®Drug
Also called Test drug, Reference drug group
Period 1: Single oral administration of 1 tablet of test drug together with 150 mL of water containing 30 g sugar.
The wash-out for fed study is 14 days. Period 2: Single oral administration of 1 tablet of reference drug together with 150 mL of water containing 30 g sugar.
Sugamet SR Tab 5/1000mg®, DA-1229_01(A)Drug
Also called Reference drug,Test drug group
Period 1: Single oral administration of 1 tablet of reference drug together with 150 mL of water containing 30 g sugar.
The wash-out for fed study is 14 days. Period 2: Single oral administration of 1 tablet of test drug together with 150 mL of water containing 30 g sugar.
| Study group | Role | What they receive |
|---|---|---|
| Test drug, Reference drug group | Experimental | Period 1: Single oral administration of 1 tablet of test drug(DA-1229_01(A)) together with 150 mL of water containing 30 g sugar.
The wash-out for fasting study is 14 days. Period 2: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar. Receives: Drug: DA-1229_01(A), Sugamet SR Tab 5/1000mg® |
| Reference drug,Test drug group | Active comparator | Period 1: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar.
The wash-out for fasting study is 14 days. Period 2: Single oral administration of 1 tablet of test drug(DA-1229_01(A)) together with 150 mL of water containing 30 g sugar. Receives: Drug: Sugamet SR Tab 5/1000mg®, DA-1229_01(A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve(AUCt)
AUCt of evogliptin and metformin
Measured: Hour -1 ~ Hour 72
Maximum plasmaconcentration of drug in plasma(Cmax)
Cmax of evogliptin and metformin
Measured: Hour -1 ~ Hour 72
Secondary outcomes (5)
Area under the plasma drug concentration-time curve from time 0 to infinity(AUCinf)
AUCinf of evogliptin and metformin
Measured: Hour -1 ~ Hour 72
AUCt/AUCinf
AUCt/AUCinf of evogliptin and metformin
Measured: Hour -1 ~ Hour 72
Time to reach the maximum plasma concentration(Tmax)
Tmax of evogliptin and metformin
Measured: Hour -1 ~ Hour 72
Terminal elimination rate constant(ramda z)
ramda z of evogliptin and metformin
Measured: Hour -1 ~ Hour 72
Terminal elimination half-life(t1/2)
t1/2 of evogliptin and metformin
Measured: Hour -1 ~ Hour 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start7 Feb 2019
- Primary completion4 Apr 2019
- Study completion4 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sung Dae Kwon, M.D., Ph.D., Principal investigator, Metro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939143
- Sponsor's protocol ID
- DDS18-033BE
- Status last verified
- May 2019
- First submitted
- 1 Apr 2019
- Last updated
- 20 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open Label, Single Oral Administration at Fasting State, 2 x 2 Crossover Study to Investigate the Bioequivalence Test of DA-1229_01(A)
- ClinicalTrials.gov ID
- NCT03939143
- Acronym / sponsor ID
- DDS18-033BE
- Conditions
- Type2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 4 Apr 2019 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 6 May 2019 (actual)
- 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.
A study demonstrates the bioequivalence of DA-1229_01(A) at Fasting State when compared with Sugamet sustained-release(SR) Tab 5/1000mg® in healthy adults
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test drug, Reference drug group | Experimental | Drug: DA-1229_01(A), Sugamet SR Tab 5/1000mg®Period 1: Single oral administration of 1 tablet of test drug(DA-1229_01(A)) together with 150 mL of water containing 30 g sugar. The wash-out for fasting study is 14 days. Period 2: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar. |
| Reference drug,Test drug group | Active comparator | Drug: Sugamet SR Tab 5/1000mg®, DA-1229_01(A)Period 1: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar. The wash-out for fasting study is 14 days. Period 2: Single oral administration of 1 tablet of test drug(DA-1229_01(A)) together with 150 mL of water containing 30 g sugar. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients over 19 years of age at the time of health examination
- Female patients who were confirmed to be not pregnant at health examination
- Patients without a history of mental illness in the past 5 years
Key exclusion criteria (4 listed)
- Patients who have taken medications which could affect the results of the clinical trial in the past 10 days of participating in the clinical trial
- Patients with a congestive heart failure which requires medicinal treatment
- Patients who have made a whole blood donation in the past 2 months or an apheresis donation in the past 2 weeks of participating in the clinical trial
- Female patients who are lactating
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_01(A), Sugamet SR Tab 5/1000mg®Also: Test drug, Reference drug groupPeriod 1: Single oral administration of 1 tablet of test drug together with 150 mL of water containing 30 g sugar. The wash-out for fed study is 14 days. Period 2: Single oral administration of 1 tablet of reference drug together with 150 mL of water containing 30 g sugar. | Drug | Test drug, Reference drug group |
| Sugamet SR Tab 5/1000mg®, DA-1229_01(A)Also: Reference drug,Test drug groupPeriod 1: Single oral administration of 1 tablet of reference drug together with 150 mL of water containing 30 g sugar. The wash-out for fed study is 14 days. Period 2: Single oral administration of 1 tablet of test drug together with 150 mL of water containing 30 g sugar. | Drug | Reference drug,Test drug group |
Primary outcome
Area under the concentration-time curve(AUCt)
Time frame: Hour -1 ~ Hour 72
AUCt of evogliptin and metformin
Maximum plasmaconcentration of drug in plasma(Cmax)
Time frame: Hour -1 ~ Hour 72
Cmax of evogliptin and metformin
5 secondary outcomes
Area under the plasma drug concentration-time curve from time 0 to infinity(AUCinf)
Time frame: Hour -1 ~ Hour 72
AUCt/AUCinf
Time frame: Hour -1 ~ Hour 72
Time to reach the maximum plasma concentration(Tmax)
Time frame: Hour -1 ~ Hour 72
Terminal elimination rate constant(ramda z)
Time frame: Hour -1 ~ Hour 72
Terminal elimination half-life(t1/2)
Time frame: Hour -1 ~ Hour 72
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 20 May 2020.
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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.
Sung Dae Kwon, M.D., Ph.D. principal investigator
Metro 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(A), Sugamet SR Tab 5/1000mg® and Sugamet SR Tab 5/1000mg®, DA-1229_01(A) 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 4 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 20 May 2020. 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 the concentration-time curve(AUCt) (time frame: Hour -1 ~ Hour 72). 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?
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 20 May 2020.