Study Stopped
Study ended after diabetes development plan review. .
Evaluate the Safety and Tolerability of INCB019602 When Administered With Metformin in Patients With Type 2 Diabetes
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
1 other identifier
interventional
48
1 country
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 type-2-diabetes
Started May 2008
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 13, 2008
CompletedFirst Posted
Study publicly available on registry
June 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedOctober 30, 2012
October 1, 2012
9 months
June 13, 2008
October 25, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and tolerability as determined by monitoring of AEs, vital signs, ECGs, physical examinations, and clinical laboratory blood and urine parameters.
End of Study
Secondary Outcomes (1)
Change from Baseline in fasting plasma glucose and population pharmacokinetics of INCB019602 in type 2 diabetic patients.
End of Study
Study Arms (6)
Treatment A
EXPERIMENTAL5 mg of INCB019602 in AM with placebo administration in PM
Treatment B
EXPERIMENTAL20 mg of INCB019602 in AM with placebo administration in PM
Treatment C
EXPERIMENTAL5 mg of INCB019602 in PM with placebo administration in AM
Treatment D
EXPERIMENTAL20 mg of INCB019602 in PM with placebo administration in AM
Treatment E
EXPERIMENTAL7.5 mg of INCB019602 in PM QoD with placebo administration in AM as well as PM on non active dose days
Treatment F
PLACEBO COMPARATORPlacebo BID
Interventions
Eligibility Criteria
You may qualify if:
- Established diagnosis of T2D
- Currently taking metformin monotherapy at a stable dose level
- FPG between 150 and 270 mg/dL
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Unknown Facility
Phoenix, Arizona, 85029, United States
Unknown Facility
Tucson, Arizona, 85705, United States
Unknown Facility
Chula Vista, California, 91911, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Mission Viejo, California, 92691, United States
Unknown Facility
Orange, California, 92869, United States
Unknown Facility
Paramount, California, 90723, United States
Unknown Facility
San Diego, California, 92117, United States
Unknown Facility
Santa Ana, California, 92701, United States
Unknown Facility
Tustin, California, 92780, United States
Unknown Facility
Colorado Springs, Colorado, 80909, United States
Unknown Facility
St. Petersburg, Florida, 33709, United States
Unknown Facility
Shawnee Mission, Kansas, 66216, United States
Unknown Facility
Shreveport, Louisiana, 71101, United States
Unknown Facility
Dearborn, Michigan, 48126, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Omaha, Nebraska, 68154, United States
Unknown Facility
Elizabeth, New Jersey, 07202, United States
Unknown Facility
Charlotte, North Carolina, 28211, United States
Unknown Facility
Oklahoma City, Oklahoma, 73103, United States
Unknown Facility
East Providence, Rhode Island, 02914, United States
Unknown Facility
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
William V Williams, MD
Incyte Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2008
First Posted
June 17, 2008
Study Start
May 1, 2008
Primary Completion
February 1, 2009
Study Completion
June 1, 2009
Last Updated
October 30, 2012
Record last verified: 2012-10