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Ginseng, Wheat Bran

Phase 1

Diabetes Mellitus Type 2 | Unknown | Cardiovascular |Unity Biotechnology, Inc.|Last Updated: Nov 21, 2018

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 Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01578837Combined Rg3-enriched Korean Red Ginseng and American Ginseng in the Management of Hypertension in Type 2 DiabetesPHASE1 COMPLETED 90Apr 1, 2014Sep 1, 2017Nov 21, 20182 Canada, Croatia
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Study Endpoints
Primary Endpoints
Change in Mean 24 hour Systolic Ambulatory Blood Pressure at 12 weeks
12 Weeks
Secondary Endpoints
Change in Mean 24 hour Diastolic, daytime and nighttime Ambulatory Blood pressure at 12 Weeks
12 Weeks
Change in Pulse Pressure
12 Weeks
Change in Central Augmentation Index and pulse wave analysis
12 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GinsengEXPERIMENTALCombined Rg3-enriched Korean Red Ginseng and American Ginseng capsule
Wheat BranPLACEBO_COMPARATOR100 % Natural Wheat Bran capsule
Interventions
NameTypeDescription
GinsengDIETARY_SUPPLEMENT2.25g of encapsulated ginseng (1.5g American Ginseng and 0.75g Rg3-enriched Korean Red Ginseng)will be administered in 6 identical capsules, 2 capsules with each meal (total 6 capsules per day).
Wheat BranDIETARY_SUPPLEMENT2.25g of encapsulated 100% natural wheat bran will be administered in 6 identical capsules, 2 capsules with each meal (total 6 capsules per day).
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Eligibility Criteria
Age Range40 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * between the age of 40 and 75 years * type 2 diabetes (at least 1 year duration, HbA1c ≥ 6.5%- ≤ 8.0%, treated with diet and/or oral hypoglycemic medications) * clinically diagnosed and treated hypertension according to Canadian Diabetes Association Clinical Practice Guidelines...

Countries:CanadaCroatia
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