Recent Updates
Recently added Catalysts

AR-C165395XX

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

AR-C165395XX · 1 trial · 1 indication

Phase 1 1
NCT02367066A Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX in Subjects With Type 2 Diabetes Mellitus (T2DM)Type 2 Diabetes Mellitus
COMPLETED30 Analytics
PHASE1COMPLETED
A Phase I Study to Assess the Pharmacodynamics of Oral AR-C165395XX in Subjects With Type 2 Diabetes Mellitus (T2DM)
Type 2 Diabetes Mellitus
NCT0236706630
Unlock trial analytics

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
Unlock Study Endpoints

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)
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about AR-C165395XX

What is AR-C165395XX used for?

AR-C165395XX is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes AR-C165395XX?

AR-C165395XX is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN.

What phase is AR-C165395XX in?

AR-C165395XX is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval for any use.

What clinical trials is AR-C165395XX in?

AR-C165395XX has one completed Phase 1 clinical trial, identified as NCT02367066. This study assessed the pharmacodynamics of oral AR-C165395XX in subjects with Type 2 Diabetes Mellitus and enrolled 30 participants in the United States.

Is AR-C165395XX FDA approved?

AR-C165395XX is not FDA approved. It is an investigational drug currently in Phase 1 clinical development, and its safety and efficacy have not been established for any indication.