Type 2 Diabetes MellitusPhase 1NCT01941199
Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 and Metformin After Oral Administration in Healthy Male Subjects
A Phase 1 study testing DA-1229, metformin and DA-1229 + metformin in people with Type 2 Diabetes Mellitus, run by Dong-A Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This is a randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of DA-1229 5 mg and Metformin IR 1000 mg after oral administration 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, metformin and DA-1229 + metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Nov 2013
- 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 70-125mg/dL glucose level(at screening)
- Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.
Who cannot join
- Subject 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)
- Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
- Subject 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 in 1 months currently.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trial Center, Seoul National University Hospital
Seoul, 110-744
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 DA-1229 5 mg and Metformin IR 1000 mg After Oral Administration in Healthy Male Volunteers
This is a randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of DA-1229 5 mg and Metformin IR 1000 mg after oral administration in healthy male volunteers.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- DA-1229, metformin, DA-1229 + metformin
- 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-1229Drug
metforminDrug
DA-1229 + metforminDrug
| Study group | Role | What they receive |
|---|---|---|
| D → M → D+M | Experimental | D : DA-1229 5mg qd, M : metformin 1000mg bid Receives: Drug: DA-1229; Drug: metformin; Drug: DA-1229 + metformin |
| D → D+M → M | Experimental | D : DA-1229 5mg qd, M : metformin 1000mg bid Receives: Drug: DA-1229; Drug: metformin; Drug: DA-1229 + metformin |
| M → D → D+M | Experimental | D : DA-1229 5mg qd, M : metformin 1000mg bid Receives: Drug: DA-1229; Drug: metformin; Drug: DA-1229 + metformin |
| M → D+M → D | Experimental | D : DA-1229 5mg qd, M : metformin 1000mg bid Receives: Drug: DA-1229; Drug: metformin; Drug: DA-1229 + metformin |
| D+M → M → D | Experimental | D : DA-1229 5mg qd, M : metformin 1000mg bid Receives: Drug: DA-1229; Drug: metformin; Drug: DA-1229 + metformin |
| D+M → D → M | Experimental | D : DA-1229 5mg qd, M : metformin 1000mg bid Receives: Drug: DA-1229; Drug: metformin; Drug: DA-1229 + metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ,ss of DA-1229 and metformin
Measured: up to 168h
Cmax,ss of DA-1229 and metformin
Measured: up to 168h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionNov 2013
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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941199
- Sponsor's protocol ID
- DA1229_DIM_I
- Status last verified
- Nov 2013
- First submitted
- 9 Sep 2013
- Last updated
- 27 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 5 mg and Metformin IR 1000 mg After Oral Administration in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01941199
- Acronym / sponsor ID
- DA1229_DIM_I
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Nov 2013 (actual)
- First posted
- 13 Sep 2013 (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 is a randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of DA-1229 5 mg and Metformin IR 1000 mg after oral administration in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| D → M → D+M | Experimental | Drug: DA-1229, Drug: metformin, Drug: DA-1229 + metforminD : DA-1229 5mg qd, M : metformin 1000mg bid |
| D → D+M → M | Experimental | Drug: DA-1229, Drug: metformin, Drug: DA-1229 + metforminD : DA-1229 5mg qd, M : metformin 1000mg bid |
| M → D → D+M | Experimental | Drug: DA-1229, Drug: metformin, Drug: DA-1229 + metforminD : DA-1229 5mg qd, M : metformin 1000mg bid |
| M → D+M → D | Experimental | Drug: DA-1229, Drug: metformin, Drug: DA-1229 + metforminD : DA-1229 5mg qd, M : metformin 1000mg bid |
| D+M → M → D | Experimental | Drug: DA-1229, Drug: metformin, Drug: DA-1229 + metforminD : DA-1229 5mg qd, M : metformin 1000mg bid |
| D+M → D → M | Experimental | Drug: DA-1229, Drug: metformin, Drug: DA-1229 + metforminD : DA-1229 5mg qd, M : metformin 1000mg bid |
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 70-125mg/dL glucose level(at screening)
- Subject who totally understand 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)
- Subject 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)
- Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
- Subject 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 in 1 months currently.
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 | Drug | D → D+M → M, D → M → D+M, D+M → D → M, D+M → M → D, M → D → D+M, M → D+M → D |
| metformin | Drug | D → D+M → M, D → M → D+M, D+M → D → M, D+M → M → D, M → D → D+M, M → D+M → D |
| DA-1229 + metformin | Drug | D → D+M → M, D → M → D+M, D+M → D → M, D+M → M → D, M → D → D+M, M → D+M → D |
Primary outcome
AUCτ,ss of DA-1229 and metformin
Time frame: up to 168h
Cmax,ss of DA-1229 and metformin
Time frame: up to 168h
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 27 Nov 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, metformin and DA-1229 + metformin in people with Type 2 Diabetes Mellitus, run by Dong-A Pharmaceutical 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 27 Nov 2013. 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 of DA-1229 and metformin (time frame: up to 168h). 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 27 Nov 2013.