Type 2 Diabetes MellitusPhase 1NCT00964262
A Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of Sustained Release(SR) Exenatide
A Phase 1 study testing SR Exenatide (PT302) in people with Type 2 Diabetes Mellitus, run by Peptron, Inc. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of SR exenatide (PT302) in healthy 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
- Type 2 Diabetes Mellitus
- What is being tested?
- SR Exenatide (PT302)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2009to Oct 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
- Healthy male subjects aged 20-45 years at screening
- Body weight over 50 kg, inclusive, and within 20% of ideal body weight
Who cannot join
- Has a present illness or medical history of hepatic, renal, respiratory, cardiovascular disease, blood tumor, mental disorder, and endocrinologic disorder, especially diabetes mellitus
- Has a sign or symptom or history related to an acute or chronic pancreatitis
- Has a known allergy or hypersensitivity to exenatide or other drugs such as aspirin, antibiotics, and so on
- Has ever been exposed to exenatide
- Shows SBP >= 150 mmHg or <= 90 mmHg or DBP >= 100 mmHg or <= 50 mmHg
- Has a presence or history of drug abuse
Show all 12Show fewer
- Uses any prescription drug, herbal medicine within 2 weeks or OTC drugs or vitamin within 1 week prior to study drug administration
- Has been participated in other clinical trial within 2 months
- Has experience of a blood donation during 2 months or a blood transfusion during 1 month prior to study drug administration
- Heavy smoker more than 10 cigarettes/day within 3 months prior to screening
- Continuous drinker (over 21 units/week, 1 unit = 10 g of pure alcohol) or subject who can't quit drinking nor smoking during clinical trial period
- Subjects not eligible at the discretion of investigators
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trials Center, Seoul National University Hospital
Seoul, 110-744
About this study
Official title: A Dose Block-randomized, Double-blind, Placebo-controlled, Dose-escalating Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of SR Exenatide (PT302) After Subcutaneous Injection in Healthy Male Volunteers
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of SR exenatide (PT302) in healthy subjects.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- SR Exenatide (PT302), Placebo
- Keywords
- diabetes, exenatide, SR exenatide, Peptron
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR Exenatide (PT302)Drug
0.5 mg, 1.0 mg, 2.0 mg and 4.0 mg dosage(dose escalation), single subcutaneous injection
PlaceboDrug
Plcacebo of each doasage, single subcutanoeus injection
| Study group | Role | What they receive |
|---|---|---|
| SR Exenatide (PT302) | Experimental | Intervention: Drug: SR Exenatide (PT302) Receives: Drug: SR Exenatide (PT302); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and pharmacokinetics of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection
Measured: 8 weeks
Secondary outcomes (1)
To examine the effect on glucose control and pharmacodynamic parameters of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2010
- Study completionOct 2010
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 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peptron, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-Sang Yu, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964262
- Sponsor's protocol ID
- PepE01
- Status last verified
- May 2013
- First submitted
- 21 Aug 2009
- Last updated
- 19 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gu N, Cho SH, Kim J, Shin D, Seol E, Lee H, Lim KS, Shin SG, Jang IJ, Yu KS. Pharmacokinetic properties and effects of PT302 after repeated oral glucose loading tests in a dose-escalating study. Clin Ther. 2014 Jan 1;36(1):101-14. doi: 10.1016/j.clinthera.2013.12.002. Epub 2013 Dec 27.
PubMed 24373998
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 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 Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of SR Exenatide (PT302) After Subcutaneous Injection in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00964262
- Acronym / sponsor ID
- PepE01
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes, exenatide, SR exenatide, Peptron
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Peptron, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 24 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.
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of SR exenatide (PT302) in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SR Exenatide (PT302) | Experimental | Drug: SR Exenatide (PT302), Drug: PlaceboIntervention: Drug: SR Exenatide (PT302) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male subjects aged 20-45 years at screening
- Body weight over 50 kg, inclusive, and within 20% of ideal body weight
Key exclusion criteria (12 listed)
- Has a present illness or medical history of hepatic, renal, respiratory, cardiovascular disease, blood tumor, mental disorder, and endocrinologic disorder, especially diabetes mellitus
- Has a sign or symptom or history related to an acute or chronic pancreatitis
- Has a known allergy or hypersensitivity to exenatide or other drugs such as aspirin, antibiotics, and so on
- Has ever been exposed to exenatide
- Shows SBP >= 150 mmHg or <= 90 mmHg or DBP >= 100 mmHg or <= 50 mmHg
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 Exenatide (PT302)0.5 mg, 1.0 mg, 2.0 mg and 4.0 mg dosage(dose escalation), single subcutaneous injection | Drug | SR Exenatide (PT302) |
| PlaceboPlcacebo of each doasage, single subcutanoeus injection | Drug | SR Exenatide (PT302) |
Primary outcome
To evaluate the safety and pharmacokinetics of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection
Time frame: 8 weeks
1 secondary outcome
To examine the effect on glucose control and pharmacodynamic parameters of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection
Time frame: 8 weeks
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 19 Jul 2013.
- Derived from this study: PubMed 24373998Gu N, Cho SH, Kim J, Shin D, Seol E, Lee H, Lim KS, Shin SG, Jang IJ, Yu KS. Pharmacokinetic properties and effects of PT302 after repeated oral glucose loading tests in a dose-escalating study. Clin Ther. 2014 Jan 1;36(1):101-14. doi: 10.1016/j.clinthera.2013.12.002. Epub 2013 Dec 27.
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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, MD, PhD 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 (PT302) in people with Type 2 Diabetes Mellitus, run by Peptron, Inc. 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 12 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 19 Jul 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?
To evaluate the safety and pharmacokinetics of SR exenatide (PT302) in healthy subjects after a single subcutaneous injection (time frame: 8 weeks). 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 NCT00964262, 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 19 Jul 2013.