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ITCA 650/day

Phase 3

Type 2 Diabetes | Small molecule | Metabolic |cbdMD, Inc.|Last Updated: Jun 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment535

FDA Designations

No designations recorded

Clinical trial landscape

ITCA 650/day · 1 trial · 1 indication

Phase 3 1
NCT01455870A Study to Evaluate ITCA 650 Compared to Sitagliptin as add-on Therapy for the Treatment of Type 2 DiabetesType 2 Diabetes
COMPLETED535 Analytics
PHASE3COMPLETED
A Study to Evaluate ITCA 650 Compared to Sitagliptin as add-on Therapy for the Treatment of Type 2 Diabetes
Type 2 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in HbA1c between Week 52 and Day 0
52 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ITCA 650 60 mcg/dayEXPERIMENTALITCA 650 is exenatide in DUROS
sitagliptinACTIVE_COMPARATORsitagliptin 100 mg/day

Interventions

NameTypeDescription
ITCA 650 60 mcg/dayDRUGexenatide in DUROS
sitagliptinDRUGoral sitagliptin 100 mg/day
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites54

Inclusion Criteria: * HbA1c between 7.5% - 10.5% * on metformin monotherapy * BMI between 25 \& 45 kg/m2 Exclusion Criteria: * taking thiazolidinedione, sulfonylurea, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months * history of pancreatitis

Countries:United StatesCroatiaDenmarkGermanyLatvia
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Frequently asked questions about ITCA 650/day

What is ITCA 650/day used for?

ITCA 650/day is an investigational small molecule being developed for the treatment of Type 2 Diabetes. It is a metabolic therapeutic that has been studied as an add-on therapy for patients with this condition. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.

Who makes ITCA 650/day?

ITCA 650/day is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical research on this investigational drug for Type 2 Diabetes, with the asset currently in Phase 3 development.

What phase is ITCA 650/day in?

ITCA 650/day is in Phase 3 clinical development for Type 2 Diabetes. It is an investigational drug, meaning it has not been approved by regulatory agencies. One Phase 3 trial has been completed, and there are no active trials currently listed for this asset.

What clinical trials is ITCA 650/day in?

ITCA 650/day has one completed Phase 3 clinical trial registered under NCT01455870. This study evaluated ITCA 650 compared to sitagliptin as add-on therapy for Type 2 Diabetes, enrolling 535 participants across the United States, Croatia, Denmark, Germany, and Latvia. The trial was randomized, double-blind, and active-controlled.

Is ITCA 650/day the same as any other drug?

ITCA 650/day is the primary name used for this investigational drug in clinical development. No alternative names have been reported for this asset. It is being studied specifically for Type 2 Diabetes and is not known to be marketed under any other designation.