Diabetes MellitusPhase 1SR-ExenatideNCT01156779
Study to Evaluate Safety and PK/PD of DA-3091 in Healthy Male Subjects
A Phase 1 study testing SR-exenatide in people with Diabetes Mellitus, run by Dong-A Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This Phase I clinical study is to evaluate the safety and tolerance of DA-3091 and to characterize the pharmacokinetic/pharmacodynamic of DA-3091 in healthy male subjects 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 Mellitus
- What is being tested?
- SR-exenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2010to Apr 2012
- 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 : 20 ~ 45 years old
- Healthy Male
- Body weight : ≥50kg and Ideal body weight ± 20%
- Informed consent
Who cannot join
- Clinically significant medical history
- Acute or Chronic pancreatitis
- Clinically significant hypersensitivity of Drugs
- Clinically significant cutaneous disorder
- History of administration of exenatide
- Disorder of blood pressure
- History of drug abuse
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trial center, Clinical Research institute, Seoul National University Hospital
Seoul
About this study
Official title: A Dose Block-randomized, Double-blind, Placebo-controlled, Dose-escalating, Phase I Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of DA-3091 After Subcutaneous Injection in Healthy Male Subjects
This Phase I clinical study is to evaluate the safety and tolerance of DA-3091 and to characterize the pharmacokinetic/pharmacodynamic of DA-3091 in healthy male subjects
Read the detailed description
This is a phase I dose escalation study. To meet the clinical objectives, we are using a two-part approach. In part I, 4 subjects are injected 0.5mg dose of DA-3091 or placebo(Single/Subcutaneous Injection). After completion of part I study, we are reporting data about safety to IDMC. In part II, 8 subjects per group are injected 1mg, 2mg, 4mg of DA-3091 or placebo through dose escalating protocol. The ratio of DA-3091 and placebo is 3:1.
- Conditions
- Diabetes Mellitus
- Being tested
- SR-exenatide
- Keywords
- SR-Exenatide
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR-exenatideDrug
Also called DA-3091
Emulsion 0.5mg,1mg,2mg,4mg dosage (Dose-escalation) Single injection
| Study group | Role | What they receive |
|---|---|---|
| DA-3091 | Experimental | SR-exenatide Receives: Drug: SR-exenatide |
| Placebo of DA-3091 | Placebo comparator | Placebo Receives: Drug: SR-exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety
- Adverse Events
- Laboratory Results
- Vital sign, Physical Examination, EKG
Measured: 84 days
Secondary outcomes (1)
Pharmacokinetics and Pharmacodynamics
PK : Cmax, Tmax, AUClast PD : Glucose, Insulin, Glucagon, C-peptide in blood sample
Measured: PK : 84 days / PD : 42days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-Sang Yu, M.D., Ph.d, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156779
- Sponsor's protocol ID
- DA3091_DM_I
- Acronym
- SR-Exenatide
- Status last verified
- Aug 2013
- First submitted
- 2 Jul 2010
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Block-randomized, Double-blind, Placebo-controlled, Dose-escalating, Phase I Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of DA-3091 After Subcutaneous Injection in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01156779
- Acronym / sponsor ID
- SR-Exenatide / DA3091_DM_I
- Conditions
- Diabetes Mellitus
- Keywords
- SR-Exenatide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Dong-A Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Apr 2012 (actual)
- First posted
- 5 Jul 2010 (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 Phase I clinical study is to evaluate the safety and tolerance of DA-3091 and to characterize the pharmacokinetic/pharmacodynamic of DA-3091 in healthy male subjects
Detailed description
This is a phase I dose escalation study. To meet the clinical objectives, we are using a two-part approach. In part I, 4 subjects are injected 0.5mg dose of DA-3091 or placebo(Single/Subcutaneous Injection). After completion of part I study, we are reporting data about safety to IDMC. In part II, 8 subjects per group are injected 1mg, 2mg, 4mg of DA-3091 or placebo through dose escalating protocol. The ratio of DA-3091 and placebo is 3:1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-3091 | Experimental | Drug: SR-exenatideSR-exenatide |
| Placebo of DA-3091 | Placebo comparator | Drug: SR-exenatidePlacebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age : 20 ~ 45 years old
- Healthy Male
- Body weight : ≥50kg and Ideal body weight ± 20%
- Informed consent
Key exclusion criteria (7 listed)
- Clinically significant medical history
- Acute or Chronic pancreatitis
- Clinically significant hypersensitivity of Drugs
- Clinically significant cutaneous disorder
- History of administration of exenatide
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 |
|---|---|---|
| SR-exenatideAlso: DA-3091Emulsion 0.5mg,1mg,2mg,4mg dosage (Dose-escalation) Single injection | Drug | DA-3091, Placebo of DA-3091 |
Primary outcome
Assessment of safety
Time frame: 84 days
1. Adverse Events 2. Laboratory Results 3. Vital sign, Physical Examination, EKG
1 secondary outcome
Pharmacokinetics and Pharmacodynamics
Time frame: PK : 84 days / PD : 42days
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 13 Aug 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.
Kyung-Sang Yu, M.D., Ph.d 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 SR-exenatide in people with 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 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: finished, as of the sponsor's last update on 13 Aug 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. 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?
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?
Assessment of safety (time frame: 84 days). 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 13 Aug 2013.