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Salba , Oat-based Control

Phase 2

Diabetes Mellitus | Unknown | Metabolic |Unity Biotechnology, Inc.|Last Updated: Oct 5, 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 Enrollment77
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01403571Effectiveness and Safety of Salba on Weight Loss in Overweight Individuals With Type 2 DiabetesPHASE2 COMPLETED 77Oct 1, 2009Aug 1, 2015Oct 5, 20161 Canada
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Study Endpoints
Primary Endpoints
Weight
24 weeks

24 week timeframe for Weightloss phase

Secondary Endpoints
Body composition
24 weeks
Blood sugar control
24 weeks
Low grade body inflammation
24 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Salba supplementEXPERIMENTAL30g/1000kal
Oat-bran based Control SupplementPLACEBO_COMPARATOR36g/1000kcal
Interventions
NameTypeDescription
Salba (Salvia hispanica L.)DIETARY_SUPPLEMENT30g/1000kcal/day over 24 wks
Oat-based ControlDIETARY_SUPPLEMENTPlacebo: 36g/1000kcal/day over 24 weeks
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Eligibility Criteria
Age Range35 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Well-controlled type 2 diabetes for at least 1 year * Treated with diet and/or oral hypoglycemic medications * BMI 25-40 kg/m2 Exclusion Criteria: * Weight change in the past three months \>10% of body weight * On insulin therapy * Unstable angina, myocardial infarction or s...

Countries:Canada
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