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INCB013739

Phase 2

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

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment302
FDA Designations
No designations recorded
Clinical trial landscape

INCB013739 · 2 trials · 3 indications

Phase 2 2
NCT00698230Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 DiabeticsType 2 Diabetes
COMPLETED302 Analytics
NCT00478322Pharmacodynamic Study of the Effect of INCB013739 on Insulin Sensitivity in Obese, Type 2 Diabetic SubjectsDiabetes Mellitus, Type 2
COMPLETED24 Analytics
PHASE2COMPLETED
Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetics
Type 2 Diabetes
NCT00698230302
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PHASE2COMPLETED
Pharmacodynamic Study of the Effect of INCB013739 on Insulin Sensitivity in Obese, Type 2 Diabetic Subjects
Diabetes Mellitus, Type 2
NCT0047832224
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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)
Changes in lipid profile laboratory values
Measured at baseline and weekly for four weeks
Assessment of pharmacokinetics of INCB013739 through analysis of blood samples.
Measured at baseline and weekly for four weeks
Assessment of pharmacodynamics of INCB013739 through analysis of blood samples
Measured at baseline and weekly for four weeks
Assessment of ECGs, physical examinations and laboratory values for adverse events
Measured at baseline through study completion
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
INCB013739EXPERIMENTAL -
Matching PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
INCB013739DRUGINCB013739 5 mg QD tablet
Placebo comparator matching INCB013739DRUGOrally once daily tablet
MetforminDRUG -
PlaceboDRUGMatching placebo of 100 mg BID
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Eligibility Criteria
Age Range18 Years to 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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Competitive Landscape -Type 2 Diabetes 148 trials

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Milestone Pharmaceuticals, Inc.MIST2PHASE2CX11
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