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AR-C165395XX

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Jun 23, 2016

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 Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02367066A Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX in Subjects With Type 2 Diabetes Mellitus (T2DM)PHASE1 COMPLETED 30 — — Mar 1, 2015May 1, 2015Jun 23, 20161 United States
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Study Endpoints
Primary Endpoints
Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose
Day -1 to Day 3 and Day 6 to Day 9

MMTT=Mixed Meal Tolerance Test AUC=Area Under Curve

Change From Baseline to Endpoint MMTT C_max for Plasma Glucose
Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma C-Peptide
Day -1 to Day 3 and Day 6 to Day 9

GGI=Glucose and GLP1 infusion AUC=Area Under Curve

Secondary Endpoints
Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Insulin
Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline MMTT AUC(0-4h) for Plasma Glucagon
Day -1 to Day 3 and Day 6 to Day 9
Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma C-Peptide
Day -1 to Day 3 and Day 6 to Day 9
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
AR-C165395XX + placeboEXPERIMENTAL1st period AR-C165395XX 2nd period placebo
Placebo + AR-C165395XXPLACEBO_COMPARATOR1st period Placebo for AR-C165395XX 2nd period AR-C165395XX
Interventions
NameTypeDescription
AR-C165395XXDRUGOral dose of AR-C165395XX (tablets)
PlaceboOTHEROral dose of placebo for AR-C165395XX (tablets)
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Eligibility Criteria
Age Range18 Years — 130 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria * Provision of informed consent * Male or female of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/tubal ligation) aged ≥18. * Patients with HbA1c ≥7.5 but ≤11% at enrolment visit (Visit 1) * ody mass ...

Countries:United States
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