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INCB013739

Phase 2

Type 2 Diabetes | Small molecule | Metabolic |Incyte Corporation|Last Updated: Feb 14, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment302
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00698230Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 DiabeticsPHASE2 COMPLETED 302May 1, 2008May 1, 2009Feb 14, 201868 United States, Puerto Rico
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Study Endpoints
Primary Endpoints
Change from Baseline to Week 12 in hemoglobin A1c (HbA1c)
Baseline and Week 12 (or early termination study visit)
Secondary Endpoints
Change from Baseline to Week 12 in fasting plasma glucose (FPG).
Baseline and Week 12 (or early termination study visit)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment A - INCB013739 & MetforminEXPERIMENTALINCB013739 5 mg QD and Metformin
Treatment B - INCB013739 & MetforminEXPERIMENTALINCB013739 15 mg QD and Metformin
Treatment C - INCB013739 & MetforminEXPERIMENTALINCB013739 50 mg QD and Metformin
Treatment D - INCB013739 & MetforminEXPERIMENTALINCB013739 100 mg QD and Metformin
Treatment E - INCB013739 & MetforminEXPERIMENTALINCB013739 200 mg QD and Metformin
Treatment F - PlaceboPLACEBO_COMPARATORMatching placebo
Interventions
NameTypeDescription
INCB013739DRUGINCB013739 5 mg QD tablet
Placebo comparator matching INCB013739DRUGOrally once daily tablet
MetforminDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites68

Inclusion Criteria: * Established diagnosis of Type 2 Diabetes * Stable dose of metformin for more than 8 weeks Exclusion Criteria: * Subjects with Addison's disease or Cushing's Syndrome * Type 1 diabetes mellitus or secondary forms of diabetes * Subjects with uncontrolled thyroid disease * Hist...

Countries:United StatesPuerto Rico
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