Diabetes Mellitus, Type 2Phase 1NCT01054118
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of JNJ-38431055, Sitagliptin, and Co-administration of JNJ-38431055 and Sitagliptin
A Phase 1 study testing JNJ-38431055, Sitagliptin 100 mg and JNJ-38431055 + Sitagliptin 100 mg in people with Diabetes Mellitus, Type 2, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in United States.
Trial summary
This study will assess the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and pharmacodynamics (explores what a drug does to the body) of single doses of JNJ-38431055, sitagliptin, and co-administration of JNJ-38431055 and sitagliptin in healthy overweight or obese adult male… Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- JNJ-38431055, Sitagliptin 100 mg and JNJ-38431055 + Sitagliptin 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Feb 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) between 27.0 and 38.0 kg/m2 (inclusive)
- Healthy on the basis of physical examination including medical history, vital signs, 12-lead ECG, and all other screening lab tests
- Men must agree to use a double barrier method of birth control (e.g., condom for them and use of spermicide with diaphragm, hormonal contraceptives or intrauterine devices by female partner) during the study and for three months following the last dose of study medication, and to not donate sperm during the study and for 3 months after receiving the last dose of study medication
Who cannot join
- History of, or currently active, illness or medical condition or disorder that the Investigator considers to be clinically significant
- Smoker or tobacco user within the past 6 months
- History of recent major surgery (within 6 months of study start)
- Positive test for alcohol and/or drugs of abuse
- Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the volunteer to comply with the study requirements
- Any condition that, in the opinion of the investigator, would compromise the well being of the volunteer or the study or prevent the volunteer from meeting or performing study requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sitagliptin Combo Study
This study will assess the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and pharmacodynamics (explores what a drug does to the body) of single doses of JNJ-38431055, sitagliptin, and co-administration of JNJ-38431055 and sitagliptin in healthy overweight or obese adult male volunteers.
Read the detailed description
This is a double-blind (neither physician or volunteer knows the name of the assigned study drug), placebo controlled (substance containing no medication), study in healthy, overweight or obese adult male volunteers. For each volunteer, the study consists of a screening phase (up to 30 days), a treatment phase during which volunteers will receive 4 study treatments in a randomized (study sequence assigned by chance) sequence (28 days), and a follow-up phase (10 days). During the treatment phase there will be at least 7 days between each of the 4 treatments. The four treatments will be JNJ-38431055, sitagliptin, JNJ-38431055 and sitagliptin, and placebo. The following safety evaluations will be taken throughout the study: Electrocardiogram (an ECG is a painless procedure that gives a picture of the electrical activity of the heart), blood pressure, heart rate, and blood samples for laboratory tests. The primary outcome will be the effect of JNJ-38431055 and sitagliptin on glucagon like peptide-1 (GLP-1) levels. Study drug will be administered as single oral doses separated by at least 7 days. The four treatments will be JNJ-38431055, sitagliptin, JNJ-38431055 and sitagliptin, and placebo.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- JNJ-38431055, Sitagliptin 100 mg, JNJ-38431055 + Sitagliptin 100 mg, Placebo
- Keywords
- Type 2 Diabetes Mellitus
- 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.
JNJ-38431055Drug
Liquid suspension of JNJ-38431055 administered as a single dose
Sitagliptin 100 mgDrug
Capsule containing 100 mg of sitagliptin administered as a single dose
JNJ-38431055 + Sitagliptin 100 mgDrug
Liquid suspension of JNJ-38431055 administered as a single dose, and capsule containing 100 mg of sitagliptin administered as a single dose
PlaceboDrug
Placebo suspension and placebo capsule administered as single doses
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | JNJ-38431055 Liquid suspension of JNJ-38431055 administered as a single dose Receives: Drug: JNJ-38431055 |
| 002 | Active comparator | Sitagliptin 100 mg Capsule containing 100 mg of sitagliptin administered as a single dose Receives: Drug: Sitagliptin 100 mg |
| 003 | Experimental | JNJ-38431055 + Sitagliptin 100 mg Liquid suspension of JNJ-38431055 administered as a single dose and capsule containing 100 mg of sitagliptin administered as a single dose Receives: Drug: JNJ-38431055 + Sitagliptin 100 mg |
| 004 | Placebo comparator | Placebo Placebo suspension and placebo capsule administered as single doses Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLP-1 levels after a standard meal
Measured: 0-4 hours after the standard meal
Secondary outcomes (4)
To evaluate the pharmacokinetics of JNJ-38431055 administered alone and in combination with sitagliptin.
Measured: 24 hours after dosing
Assess the effect of JNJ-38431055 on appetite and satiety using a visual analogue scale (VAS)
Measured: Within 24 hours of dosing
Assess the safety and tolerability of JNJ-38431055 administered alone and in combination with sitagliptin as measured by occurrence of adverse events, ECGs, vital signs, and safety laboratory measurements.
Measured: From screening visit through follow-up visit
Assess incremental glucose changes after a meal tolerance test (MTT)
Measured: 0-4 hours after MTT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startDec 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, 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
- Crossover
- Masking
- Double blind
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054118
- Sponsor's protocol ID
- CR016348
- Status last verified
- Sep 2013
- First submitted
- 15 Jan 2010
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sitagliptin Combo Study
- ClinicalTrials.gov ID
- NCT01054118
- Acronym / sponsor ID
- CR016348
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Study completion
- Feb 2010 (actual)
- First posted
- 22 Jan 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 study will assess the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and pharmacodynamics (explores what a drug does to the body) of single doses of JNJ-38431055, sitagliptin, and co-administration of JNJ-38431055 and sitagliptin in healthy overweight or obese adult male volunteers.
Detailed description
This is a double-blind (neither physician or volunteer knows the name of the assigned study drug), placebo controlled (substance containing no medication), study in healthy, overweight or obese adult male volunteers. For each volunteer, the study consists of a screening phase (up to 30 days), a treatment phase during which volunteers will receive 4 study treatments in a randomized (study sequence assigned by chance) sequence (28 days), and a follow-up phase (10 days). During the treatment phase there will be at least 7 days between each of the 4 treatments. The four treatments will be JNJ-38431055, sitagliptin, JNJ-38431055 and sitagliptin, and placebo. The following safety evaluations will be taken throughout the study: Electrocardiogram (an ECG is a painless procedure that gives a picture of the electrical activity of the heart), blood pressure, heart rate, and blood samples for laboratory tests. The primary outcome will be the effect of JNJ-38431055 and sitagliptin on glucagon like peptide-1 (GLP-1) levels. Study drug will be administered as single oral doses separated by at least 7 days. The four treatments will be JNJ-38431055, sitagliptin, JNJ-38431055 and sitagliptin, and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: JNJ-38431055JNJ-38431055 Liquid suspension of JNJ-38431055 administered as a single dose |
| 002 | Active comparator | Drug: Sitagliptin 100 mgSitagliptin 100 mg Capsule containing 100 mg of sitagliptin administered as a single dose |
| 003 | Experimental | Drug: JNJ-38431055 + Sitagliptin 100 mgJNJ-38431055 + Sitagliptin 100 mg Liquid suspension of JNJ-38431055 administered as a single dose and capsule containing 100 mg of sitagliptin administered as a single dose |
| 004 | Placebo comparator | Drug: PlaceboPlacebo Placebo suspension and placebo capsule administered as single doses |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI) between 27.0 and 38.0 kg/m2 (inclusive)
- Healthy on the basis of physical examination including medical history, vital signs, 12-lead ECG, and all other screening lab tests
- Men must agree to use a double barrier method of birth control (e.g., condom for them and use of spermicide with diaphragm, hormonal contraceptives or intrauterine devices by female partner) during the study and for three months following the last dose of study medication, and to not donate sperm during the study and for 3 months after receiving the last dose of study medication
Key exclusion criteria (6 listed)
- History of, or currently active, illness or medical condition or disorder that the Investigator considers to be clinically significant
- Smoker or tobacco user within the past 6 months
- History of recent major surgery (within 6 months of study start)
- Positive test for alcohol and/or drugs of abuse
- Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the volunteer to comply with the study requirements
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 |
|---|---|---|
| JNJ-38431055Liquid suspension of JNJ-38431055 administered as a single dose | Drug | 001 |
| Sitagliptin 100 mgCapsule containing 100 mg of sitagliptin administered as a single dose | Drug | 002 |
| JNJ-38431055 + Sitagliptin 100 mgLiquid suspension of JNJ-38431055 administered as a single dose, and capsule containing 100 mg of sitagliptin administered as a single dose | Drug | 003 |
| PlaceboPlacebo suspension and placebo capsule administered as single doses | Drug | 004 |
Primary outcome
GLP-1 levels after a standard meal
Time frame: 0-4 hours after the standard meal
4 secondary outcomes
To evaluate the pharmacokinetics of JNJ-38431055 administered alone and in combination with sitagliptin.
Time frame: 24 hours after dosing
Assess the effect of JNJ-38431055 on appetite and satiety using a visual analogue scale (VAS)
Time frame: Within 24 hours of dosing
Assess the safety and tolerability of JNJ-38431055 administered alone and in combination with sitagliptin as measured by occurrence of adverse events, ECGs, vital signs, and safety laboratory measurements.
Time frame: From screening visit through follow-up visit
Assess incremental glucose changes after a meal tolerance test (MTT)
Time frame: 0-4 hours after MTT
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 4 Sep 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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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 JNJ-38431055, Sitagliptin 100 mg and JNJ-38431055 + Sitagliptin 100 mg in people with Diabetes Mellitus, Type 2, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in United States.
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 6 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 4 Sep 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 United States. 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?
GLP-1 levels after a standard meal (time frame: 0-4 hours after the standard meal). 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 4 Sep 2013.