Evaluate the Safety and Tolerability of INCB019602 When Administered With Metformin in Patients With Type 2 Diabetes
NCT ID: NCT00698789
Last Updated: 2012-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
48 participants
INTERVENTIONAL
2008-05-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment A
5 mg of INCB019602 in AM with placebo administration in PM
INCB019602
5 mg of INCB019602 in AM with placebo administration in PM
Placebo
Placebo administration in AM or PM depending on treatment arm dosing regimen.
Metformin
Stable dose metformin monotherapy
Treatment B
20 mg of INCB019602 in AM with placebo administration in PM
INCB019602
20 mg in AM with placebo administration in PM
Placebo
Placebo administration in AM or PM depending on treatment arm dosing regimen.
Metformin
Stable dose metformin monotherapy
Treatment C
5 mg of INCB019602 in PM with placebo administration in AM
INCB019602
5 mg in PM with placebo administration in AM
Placebo
Placebo administration in AM or PM depending on treatment arm dosing regimen.
Metformin
Stable dose metformin monotherapy
Treatment D
20 mg of INCB019602 in PM with placebo administration in AM
INCB019602
20 mg in PM with placebo administration in AM
Placebo
Placebo administration in AM or PM depending on treatment arm dosing regimen.
Metformin
Stable dose metformin monotherapy
Treatment E
7.5 mg of INCB019602 in PM QoD with placebo administration in AM as well as PM on non active dose days
INCB019602
7.5 mg in PM QoD with placebo administration in AM as well as PM on non-active dose days
Placebo
Placebo administration in AM or PM depending on treatment arm dosing regimen.
Metformin
Stable dose metformin monotherapy
Treatment F
Placebo BID
Placebo
Placebo administration in AM or PM depending on treatment arm dosing regimen.
Metformin
Stable dose metformin monotherapy
Interventions
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INCB019602
5 mg of INCB019602 in AM with placebo administration in PM
INCB019602
20 mg in AM with placebo administration in PM
INCB019602
5 mg in PM with placebo administration in AM
INCB019602
20 mg in PM with placebo administration in AM
INCB019602
7.5 mg in PM QoD with placebo administration in AM as well as PM on non-active dose days
Placebo
Placebo administration in AM or PM depending on treatment arm dosing regimen.
Metformin
Stable dose metformin monotherapy
Eligibility Criteria
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Inclusion Criteria
* Currently taking metformin monotherapy at a stable dose level
* FPG between 150 and 270 mg/dL
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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William V Williams, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Phoenix, Arizona, United States
Tucson, Arizona, United States
Chula Vista, California, United States
Los Angeles, California, United States
Mission Viejo, California, United States
Orange, California, United States
Paramount, California, United States
San Diego, California, United States
Santa Ana, California, United States
Tustin, California, United States
Colorado Springs, Colorado, United States
St. Petersburg, Florida, United States
Shawnee Mission, Kansas, United States
Shreveport, Louisiana, United States
Dearborn, Michigan, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Elizabeth, New Jersey, United States
Charlotte, North Carolina, United States
Oklahoma City, Oklahoma, United States
East Providence, Rhode Island, United States
San Antonio, Texas, United States
Countries
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Other Identifiers
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INCB 19602-201
Identifier Type: -
Identifier Source: org_study_id