Recent Updates
Recently added Catalysts

INCB013739

Phase 2

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment24

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 DiabetesUnlock trial analytics
PHASE2COMPLETED
Pharmacodynamic Study of the Effect of INCB013739 on Insulin Sensitivity in Obese, Type 2 Diabetic Subjects
Diabetes Mellitus, Type 2Unlock trial analytics

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)
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about INCB013739

What is INCB013739 used for?

INCB013739 is an investigational small molecule being developed for Type 2 Diabetes Mellitus. It has been studied in Phase 2 clinical trials for glycemic control in Type 2 diabetic patients, including in combination with metformin, and for its effect on insulin sensitivity in obese Type 2 diabetic subjects.

Who makes INCB013739?

INCB013739 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The company has conducted Phase 2 clinical trials of this investigational drug in the metabolic therapeutic area.

What phase is INCB013739 in?

INCB013739 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 2 trials have been completed, one with 302 participants and another with 24 participants, both in patients with Type 2 Diabetes.

What clinical trials is INCB013739 in?

INCB013739 has been studied in two completed Phase 2 clinical trials. NCT00478322 examined its effect on insulin sensitivity in obese Type 2 diabetic subjects with 24 participants. NCT00698230 evaluated its safety and efficacy plus metformin compared to metformin alone on glycemic control in 302 Type 2 diabetics.

Is INCB013739 the same as any other drug?

No alternative names for INCB013739 have been identified. It is known only by its code name INCB013739 in clinical trial records. The drug is an investigational small molecule developed by Incyte Corporation for the treatment of Type 2 Diabetes Mellitus.