Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetics
Randomized Study to Evaluate the Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetic Subjects
1 other identifier
interventional
302
2 countries
68
Brief Summary
Determine the effect of treatment with INCB013739 administered as an 'add-on' to metformin therapy in type 2 diabetic subjects on safety and tolerability and glycemic control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes
Started May 2008
Shorter than P25 for phase_2 type-2-diabetes
68 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
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFebruary 14, 2018
February 1, 2018
11 months
June 13, 2008
February 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline to Week 12 in hemoglobin A1c (HbA1c)
Baseline and Week 12 (or early termination study visit)
Secondary Outcomes (1)
Change from Baseline to Week 12 in fasting plasma glucose (FPG).
Baseline and Week 12 (or early termination study visit)
Study Arms (6)
Treatment A - INCB013739 & Metformin
EXPERIMENTALINCB013739 5 mg QD and Metformin
Treatment B - INCB013739 & Metformin
EXPERIMENTALINCB013739 15 mg QD and Metformin
Treatment C - INCB013739 & Metformin
EXPERIMENTALINCB013739 50 mg QD and Metformin
Treatment D - INCB013739 & Metformin
EXPERIMENTALINCB013739 100 mg QD and Metformin
Treatment E - INCB013739 & Metformin
EXPERIMENTALINCB013739 200 mg QD and Metformin
Treatment F - Placebo
PLACEBO COMPARATORMatching placebo
Interventions
Eligibility Criteria
You may qualify if:
- Established diagnosis of Type 2 Diabetes
- Stable dose of metformin for more than 8 weeks
You may not qualify if:
- Subjects with Addison's disease or Cushing's Syndrome
- Type 1 diabetes mellitus or secondary forms of diabetes
- Subjects with uncontrolled thyroid disease
- History of renal impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (68)
Unknown Facility
Birmingham, Alabama, 35242, United States
Unknown Facility
Artesia, California, United States
Unknown Facility
Calabasas, California, 91307, United States
Unknown Facility
Fresno, California, 93720, United States
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
Los Gatos, California, 95032, United States
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Santa Ana, California, United States
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Colorado Springs, Colorado, 80909, United States
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Chiefland, Florida, 32626, United States
Unknown Facility
Hollywood, Florida, 33021, United States
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Longwood, Florida, 32779, United States
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Miami, Florida, 33126, United States
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Miami Beach, Florida, 33140, United States
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Ocala, Florida, 34471, United States
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Orlando, Florida, 32806, United States
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South Miami, Florida, 33143, United States
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Tampa, Florida, 33614, United States
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Dunwoody, Georgia, 30338, United States
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Rome, Georgia, 30165, United States
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Belleville, Illinois, 62220, United States
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Shawnee Mission, Kansas, 66216, United States
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Bangor, Maine, 04401, United States
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Columbia, Maryland, 21045, United States
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Sterling Heights, Michigan, 48314, United States
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Florissant, Missouri, 63031, United States
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St Louis, Missouri, 63128, United States
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St Louis, Missouri, 63141, United States
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Las Vegas, Nevada, 89101, United States
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New York, New York, 10016, United States
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Springfield Gardens, New York, 11413, United States
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West Seneca, New York, 14224, United States
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Calabash, North Carolina, 95032, United States
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Mooresville, North Carolina, 28117, United States
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New Bern, North Carolina, 28562, United States
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Winston-Salem, North Carolina, 27103, United States
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Kettering, Ohio, 45429, United States
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Norton, Ohio, 44614, United States
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Norman, Oklahoma, 73071, United States
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Altoona, Pennsylvania, 16601, United States
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Harleysville, Pennsylvania, 19438, United States
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Jenkintown, Pennsylvania, 19046, United States
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Sellersville, Pennsylvania, 18960, United States
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Greenville, South Carolina, 29615, United States
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North Myrtle Beach, South Carolina, 29582, United States
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Spartanburg, South Carolina, 29303, United States
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Bristol, Tennessee, 37620, United States
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Austin, Texas, 78705, United States
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Dallas, Texas, 75230, United States
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Georgetown, Texas, United States
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Houston, Texas, 77004, United States
Unknown Facility
Houston, Texas, 77023, United States
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Houston, Texas, 77074, United States
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Houston, Texas, 77081, United States
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Houston, Texas, 77090, United States
Unknown Facility
Midland, Texas, 79705, United States
Unknown Facility
North Richland Hills, Texas, 76180, United States
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San Antonio, Texas, 78229, United States
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Temple, Texas, 76502, United States
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Waco, Texas, 76710, United States
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Burke, Virginia, 22015, United States
Unknown Facility
Hampton, Virginia, 23666, United States
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Milwaukee, Wisconsin, 53209, United States
Unknown Facility
Carolina, 00983, Puerto Rico
Unknown Facility
Fajardo, 00738, Puerto Rico
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Ponce, 00716, Puerto Rico
Unknown Facility
Río Grande, 00745, Puerto Rico
Unknown Facility
San Juan, 00909-1711, Puerto Rico
Unknown Facility
San Juan, 00926-2832, Puerto Rico
Related Publications (1)
Rosenstock J, Banarer S, Fonseca VA, Inzucchi SE, Sun W, Yao W, Hollis G, Flores R, Levy R, Williams WV, Seckl JR, Huber R; INCB13739-202 Principal Investigators. The 11-beta-hydroxysteroid dehydrogenase type 1 inhibitor INCB13739 improves hyperglycemia in patients with type 2 diabetes inadequately controlled by metformin monotherapy. Diabetes Care. 2010 Jul;33(7):1516-22. doi: 10.2337/dc09-2315. Epub 2010 Apr 22.
PMID: 20413513DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bill Williams, MD
Incyte Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, 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
April 1, 2009
Study Completion
May 1, 2009
Last Updated
February 14, 2018
Record last verified: 2018-02