Diabetes Mellitus, Type 2Phase 2NCT00478322
Pharmacodynamic Study of the Effect of INCB013739 on Insulin Sensitivity in Obese, Type 2 Diabetic Subjects
A Phase 2 study testing INCB013739 in people with Diabetes Mellitus, Type 2 and Obesity, run by Incyte Corporation at 3 sites in United States.
Trial summary
Purpose: A 28-day US study in patients with type 2 diabetes mellitus to assess the safety and tolerability as well as the effects of treatment with an investigational drug. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- INCB013739
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2007to Feb 2008
- Phase
- Phase 2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have an established diagnosis of Type 2 Diabetes as determined by the investigator.
- Females will be postmenopausal for at least 1 year with documented FSH > 30 IU/L.
Who cannot join
- Hypertriglyceridemia > 500 mg/dL at screening.
- BMI > 40 kg/m2.
- Receiving thiazolidinediones, insulin, or exenatide within the 3 months prior to screening.
- History or clinical manifestations of Addison's disease, Cushing's Syndrome, or other disorders involving glucocorticoids or mineralocorticoids.
- Current treatment or treatment within 30 days or five half-lives (whichever is longer) prior to the first dose of study medication with another investigational medication or current enrollment in another investigational protocol.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Chula Vista, California, 91911
Study site
San Antonio, Texas, 78229
Study site
The Bronx, New York, 10461
About this study
Purpose: A 28-day US study in patients with type 2 diabetes mellitus to assess the safety and tolerability as well as the effects of treatment with an investigational drug.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- Placebo, INCB013739
- Keywords
- Diabetes;, Type II diabetes;, Non-insulin dependent diabetes;, Obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Matching placebo of 100 mg BID
INCB013739Drug
INCB013739 100 mg BID
| Study group | Role | What they receive |
|---|---|---|
| INCB013739 | Experimental | Not described Receives: Drug: INCB013739 |
| Matching Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in lipid profile laboratory values
Measured: Measured at baseline and weekly for four weeks
Assessment of pharmacokinetics of INCB013739 through analysis of blood samples.
Measured: Measured at baseline and weekly for four weeks
Assessment of pharmacodynamics of INCB013739 through analysis of blood samples
Measured: Measured at baseline and weekly for four weeks
Assessment of ECGs, physical examinations and laboratory values for adverse events
Measured: Measured at baseline through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startApr 2007
- Primary completionNov 2007
- Study completionFeb 2008
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.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Levy, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478322
- Sponsor's protocol ID
- INCB 13739-201
- Status last verified
- Dec 2016
- First submitted
- 22 May 2007
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Study of the Effect of INCB013739 on Insulin Sensitivity in Obese, Type 2 Diabetic Subjects
- ClinicalTrials.gov ID
- NCT00478322
- Acronym / sponsor ID
- INCB 13739-201
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Keywords
- Diabetes;, Type II diabetes;, Non-insulin dependent diabetes;, Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 24 May 2007 (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.
Purpose: A 28-day US study in patients with type 2 diabetes mellitus to assess the safety and tolerability as well as the effects of treatment with an investigational drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INCB013739 | Experimental | Drug: INCB013739 |
| Matching Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have an established diagnosis of Type 2 Diabetes as determined by the investigator.
- Females will be postmenopausal for at least 1 year with documented FSH > 30 IU/L.
Key exclusion criteria (5 listed)
- Hypertriglyceridemia > 500 mg/dL at screening.
- BMI > 40 kg/m2.
- Receiving thiazolidinediones, insulin, or exenatide within the 3 months prior to screening.
- History or clinical manifestations of Addison's disease, Cushing's Syndrome, or other disorders involving glucocorticoids or mineralocorticoids.
- Current treatment or treatment within 30 days or five half-lives (whichever is longer) prior to the first dose of study medication with another investigational medication or current enrollment in another investigational protocol.
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 |
|---|---|---|
| PlaceboMatching placebo of 100 mg BID | Drug | Matching Placebo |
| INCB013739INCB013739 100 mg BID | Drug | INCB013739 |
Primary outcome
Changes in lipid profile laboratory values
Time frame: Measured at baseline and weekly for four weeks
Assessment of pharmacokinetics of INCB013739 through analysis of blood samples.
Time frame: Measured at baseline and weekly for four weeks
Assessment of pharmacodynamics of INCB013739 through analysis of blood samples
Time frame: Measured at baseline and weekly for four weeks
Assessment of ECGs, physical examinations and laboratory values for adverse events
Time frame: Measured at baseline through study completion
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 6 Dec 2016.
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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.
Richard Levy, MD study director
Incyte Corporation
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INCB013739 in people with Diabetes Mellitus, Type 2 and Obesity, run by Incyte Corporation at 3 sites 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 2 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 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes in lipid profile laboratory values (time frame: Measured at baseline and weekly for four weeks). The study lists 4 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 6 Dec 2016.