Diabetes Mellitis Type 2Phase 1NCT00961025
A Study to Characterize the Pharmacokinetics/Pharmacodynamics and Effect of Food of DA-1229 in Healthy Male Subjects
A Phase 1 study testing DA-1229 in people with Diabetes Mellitis Type 2, run by Dong-A Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This is a dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose-escalation study. The study is designed to describe the relationship between multiple doses and pharmacokinetic/pharmacodynamic parameters of DA-1229 as well as safety profile. 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
- Diabetes Mellitis Type 2
- What is being tested?
- DA-1229
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2009to Mar 2010
- 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
- 20-45 years healthy male subjects
- Body weight :50-90kg, BMI between 18.5-25
- Blood glucose level of 70-110mg/dL on the FPG test
Who cannot join
- have a family history of diabetes
- Serum AST(SGOT), ALT(SGPT)>1.25 times upper limit of normal
- Creatinine clearance rate<80mL/min
- show SBP =<100mmHg or >=150mmHg, or DBP=<65mmHg or >=95mmHg, or tachycardia (PR>=100times/min)
- have a history of drug abuse or show positive for drug abuse or cotinine at urine screening
- smokers
- can not digest high-fat or high-calorie food(applicable only for the 10mg dose group subjects
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Clinical Trials Center, Seoul National University Hospital
Seoul, Chongo-Gu, Yon-Gon Dong, 110-744
Kyung-Sang Yu, M.D., Ph.D., M.B.A, +82-2-2072-1920, ksyu@snu.ac.kr
Kyung-Sang Yu, M.D.,Ph.D.,M.B.A.
About this study
Official title: A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose Escalation Clinical Phase 1 Study to Investigate the Safety, Tolerance, and Pharmacokinetics/Pharmacodynamics of DA-1229 in Healthy Male Subjects
This is a dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose-escalation study. The study is designed to describe the relationship between multiple doses and pharmacokinetic/pharmacodynamic parameters of DA-1229 as well as safety profile.
- Conditions
- Diabetes Mellitis Type 2
- Being tested
- DA-1229, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-1229Drug
single dose study : DA-1229 1.25,2.5,5,10,20,40,60mg
multiple dose study : DA-1229 5,10,20,40mg
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| DA-1229 | Experimental | DA-1229 Receives: Drug: DA-1229 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the pharmacokinetic/pharmacodynamic of DA-1229 in healthy male subjects
Measured: Multiple blood and urine samples will be collected for 120 hours after dosing of DA-1229
Secondary outcomes (1)
To evaluate the safety and tolerance of DA-1229
Measured: up to 10 days (single dose study), 17 days (single dose study for food effect), 20 days (multiple dose study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2009 (estimated)
- Study startMay 2009
- Primary completionFeb 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitis 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961025
- Sponsor's protocol ID
- DA1229_DM_I
- Status last verified
- Aug 2009
- First submitted
- 10 Aug 2009
- Last updated
- 24 Aug 2009
- Results posted
- No
Publications
Kim TE, Lim KS, Park MK, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Evaluation of the pharmacokinetics, food effect, pharmacodynamics, and tolerability of DA-1229, a dipeptidyl peptidase IV inhibitor, in healthy volunteers: first-in-human study. Clin Ther. 2012 Sep;34(9):1986-98. doi: 10.1016/j.clinthera.2012.08.006. Epub 2012 Sep 1.
PubMed 22943970
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose Escalation Clinical Phase 1 Study to Investigate the Safety, Tolerance, and Pharmacokinetics/Pharmacodynamics of DA-1229 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00961025
- Acronym / sponsor ID
- DA1229_DM_I
- Conditions
- Diabetes Mellitis Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 18 Aug 2009 (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 dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose-escalation study. The study is designed to describe the relationship between multiple doses and pharmacokinetic/pharmacodynamic parameters of DA-1229 as well as safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| DA-1229 | Experimental | Drug: DA-1229DA-1229 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20-45 years healthy male subjects
- Body weight :50-90kg, BMI between 18.5-25
- Blood glucose level of 70-110mg/dL on the FPG test
Key exclusion criteria (7 listed)
- have a family history of diabetes
- Serum AST(SGOT), ALT(SGPT)>1.25 times upper limit of normal
- Creatinine clearance rate<80mL/min
- show SBP =<100mmHg or >=150mmHg, or DBP=<65mmHg or >=95mmHg, or tachycardia (PR>=100times/min)
- have a history of drug abuse or show positive for drug abuse or cotinine at urine screening
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-1229single dose study : DA-1229 1.25,2.5,5,10,20,40,60mg multiple dose study : DA-1229 5,10,20,40mg | Drug | DA-1229 |
| Placeboplacebo | Drug | Placebo |
Primary outcome
To characterize the pharmacokinetic/pharmacodynamic of DA-1229 in healthy male subjects
Time frame: Multiple blood and urine samples will be collected for 120 hours after dosing of DA-1229
1 secondary outcome
To evaluate the safety and tolerance of DA-1229
Time frame: up to 10 days (single dose study), 17 days (single dose study for food effect), 20 days (multiple dose study)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2009.
- Derived from this study: PubMed 22943970Kim TE, Lim KS, Park MK, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Evaluation of the pharmacokinetics, food effect, pharmacodynamics, and tolerability of DA-1229, a dipeptidyl peptidase IV inhibitor, in healthy volunteers: first-in-human study. Clin Ther. 2012 Sep;34(9):1986-98. doi: 10.1016/j.clinthera.2012.08.006. Epub 2012 Sep 1.
Related trials for Diabetes Mellitis Type 2
Active, not recruiting
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
Nutrition, Type 2 Diabetes
Not yet recruiting
Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabetes
Diabetes Mellitis
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.
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 in people with Diabetes Mellitis Type 2, 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 3 inclusion and 7 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 24 Aug 2009. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyung-Sang Yu, M.D., Ph.d., M.B.A. (+82-2-2072-1920, ksyu@snuh.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize the pharmacokinetic/pharmacodynamic of DA-1229 in healthy male subjects (time frame: Multiple blood and urine samples will be collected for 120 hours after dosing of DA-1229). 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 NCT00961025, which also lists 1 linked publication.
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 24 Aug 2009.