Type 2 DiabetesPhase 2NCT00698789
Evaluate the Safety and Tolerability of INCB019602 When Administered With Metformin in Patients With Type 2 Diabetes
A Phase 2 study testing INCB019602 and Metformin in people with Type 2 Diabetes, run by Incyte Corporation at 22 sites in United States.
Trial summary
Determine the effect of treatment with INCB019602 administered as an add-on to stable dose metformin therapy in type 2 diabetic subjects on safety and glycemic control. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- INCB019602 and Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 22 sitesUnited States
- Study dates
- May 2008to Jun 2009
- 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
- Established diagnosis of T2D
- Currently taking metformin monotherapy at a stable dose level
- FPG between 150 and 270 mg/dL
Who cannot join
- History or clinical manifestations of renal impairment
- Hyperglycemia > 270 mg/dL
- Receiving thiazolidenediones, Exenatide or sulfonylureas within 90 days prior to screening
- Prior use of Acipimox which is known under the name Olbetam within 90 days prior to screening.
- Diagnosed major depression within the last 2 years requiring hospitalization
- History of chronic insulin therapy for glycemic control
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Study site
Charlotte, North Carolina, 28211
Study site
Chula Vista, California, 91911
Study site
Colorado Springs, Colorado, 80909
Study site
Dearborn, Michigan, 48126
Study site
East Providence, Rhode Island, 02914
Study site
Elizabeth, New Jersey, 07202
Study site
Los Angeles, California
Study site
Mission Viejo, California, 92691
Study site
Oklahoma City, Oklahoma, 73103
Study site
Omaha, Nebraska, 68154
Study site
Orange, California, 92869
Study site
Paramount, California, 90723
Study site
Phoenix, Arizona, 85029
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92117
Study site
Santa Ana, California, 92701
Study site
Shawnee Mission, Kansas, 66216
Study site
Shreveport, Louisiana, 71101
Study site
St Louis, Missouri, 63110
Study site
St. Petersburg, Florida, 33709
Study site
Tucson, Arizona, 85705
Study site
Tustin, California, 92780
About this study
Official title: A Double-blind, Placebo Controlled, Randomized Study to Evaluate the Safety and Tolerability of INCB019602 Plus Metformin Compared to Metformin Alone in Type 2 Diabetic Subjects
Determine the effect of treatment with INCB019602 administered as an add-on to stable dose metformin therapy in type 2 diabetic subjects on safety and glycemic control.
- Conditions
- Type 2 Diabetes
- Being tested
- INCB019602, Placebo, Metformin
- 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.
INCB019602Drug
5 mg of INCB019602 in AM with placebo administration in PM
INCB019602Drug
20 mg in AM with placebo administration in PM
INCB019602Drug
5 mg in PM with placebo administration in AM
INCB019602Drug
20 mg in PM with placebo administration in AM
INCB019602Drug
7.5 mg in PM QoD with placebo administration in AM as well as PM on non-active dose days
PlaceboDrug
Placebo administration in AM or PM depending on treatment arm dosing regimen.
MetforminDrug
Stable dose metformin monotherapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | 5 mg of INCB019602 in AM with placebo administration in PM Receives: Drug: INCB019602; Drug: Placebo; Drug: Metformin |
| Treatment B | Experimental | 20 mg of INCB019602 in AM with placebo administration in PM Receives: Drug: INCB019602; Drug: Placebo; Drug: Metformin |
| Treatment C | Experimental | 5 mg of INCB019602 in PM with placebo administration in AM Receives: Drug: INCB019602; Drug: Placebo; Drug: Metformin |
| Treatment D | Experimental | 20 mg of INCB019602 in PM with placebo administration in AM Receives: Drug: INCB019602; Drug: Placebo; Drug: Metformin |
| Treatment E | Experimental | 7.5 mg of INCB019602 in PM QoD with placebo administration in AM as well as PM on non active dose days Receives: Drug: INCB019602; Drug: Placebo; Drug: Metformin |
| Treatment F | Placebo comparator | Placebo BID Receives: Drug: Placebo; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as determined by monitoring of AEs, vital signs, ECGs, physical examinations, and clinical laboratory blood and urine parameters.
Measured: End of Study
Secondary outcomes (1)
Change from Baseline in fasting plasma glucose and population pharmacokinetics of INCB019602 in type 2 diabetic patients.
Measured: End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionFeb 2009
- Study completionJun 2009
Why it stopped: Study ended after diabetes development plan review. .
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William V Williams, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698789
- Sponsor's protocol ID
- INCB 19602-201
- Status last verified
- Oct 2012
- First submitted
- 13 Jun 2008
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo Controlled, Randomized Study to Evaluate the Safety and Tolerability of INCB019602 Plus Metformin Compared to Metformin Alone in Type 2 Diabetic Subjects
- ClinicalTrials.gov ID
- NCT00698789
- Acronym / sponsor ID
- INCB 19602-201
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study ended after diabetes development plan review. .
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 17 Jun 2008 (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.
Determine the effect of treatment with INCB019602 administered as an add-on to stable dose metformin therapy in type 2 diabetic subjects on safety and glycemic control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: INCB019602, Drug: Placebo, Drug: Metformin5 mg of INCB019602 in AM with placebo administration in PM |
| Treatment B | Experimental | Drug: INCB019602, Drug: Placebo, Drug: Metformin20 mg of INCB019602 in AM with placebo administration in PM |
| Treatment C | Experimental | Drug: INCB019602, Drug: Placebo, Drug: Metformin5 mg of INCB019602 in PM with placebo administration in AM |
| Treatment D | Experimental | Drug: INCB019602, Drug: Placebo, Drug: Metformin20 mg of INCB019602 in PM with placebo administration in AM |
| Treatment E | Experimental | Drug: INCB019602, Drug: Placebo, Drug: Metformin7.5 mg of INCB019602 in PM QoD with placebo administration in AM as well as PM on non active dose days |
| Treatment F | Placebo comparator | Drug: Placebo, Drug: MetforminPlacebo BID |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Established diagnosis of T2D
- Currently taking metformin monotherapy at a stable dose level
- FPG between 150 and 270 mg/dL
Key exclusion criteria (6 listed)
- History or clinical manifestations of renal impairment
- Hyperglycemia > 270 mg/dL
- Receiving thiazolidenediones, Exenatide or sulfonylureas within 90 days prior to screening
- Prior use of Acipimox which is known under the name Olbetam within 90 days prior to screening.
- Diagnosed major depression within the last 2 years requiring hospitalization
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 |
|---|---|---|
| INCB0196025 mg of INCB019602 in AM with placebo administration in PM | Drug | Treatment A |
| INCB01960220 mg in AM with placebo administration in PM | Drug | Treatment B |
| INCB0196025 mg in PM with placebo administration in AM | Drug | Treatment C |
| INCB01960220 mg in PM with placebo administration in AM | Drug | Treatment D |
| INCB0196027.5 mg in PM QoD with placebo administration in AM as well as PM on non-active dose days | Drug | Treatment E |
| PlaceboPlacebo administration in AM or PM depending on treatment arm dosing regimen. | Drug | Treatment A, Treatment B, Treatment C, Treatment D, Treatment E, Treatment F |
| MetforminStable dose metformin monotherapy | Drug | Treatment A, Treatment B, Treatment C, Treatment D, Treatment E, Treatment F |
Primary outcome
Safety and tolerability as determined by monitoring of AEs, vital signs, ECGs, physical examinations, and clinical laboratory blood and urine parameters.
Time frame: End of Study
1 secondary outcome
Change from Baseline in fasting plasma glucose and population pharmacokinetics of INCB019602 in type 2 diabetic patients.
Time frame: End of Study
Results and safety
The study was stopped early (reason given: Study ended after diabetes development plan review. .). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
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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.
William V Williams, MD study director
Incyte Corporation
22 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 INCB019602 and Metformin in people with Type 2 Diabetes, run by Incyte Corporation at 22 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 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: stopped early, as of the sponsor's last update on 30 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 was stopped early (reason given: Study ended after diabetes development plan review. .). Results are not available in the source record.
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?
Safety and tolerability as determined by monitoring of AEs, vital signs, ECGs, physical examinations, and clinical laboratory blood and urine parameters. (time frame: End of Study). 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 30 Oct 2012.