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Salba diet

Phase 2

Type 2 Diabetes | Unknown | Metabolic |Unity Biotechnology, Inc.|Last Updated: Aug 9, 2006

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00362011Effect of Chia Seeds (Salvia Hispanica L.) on Glucose Control in Patients With Type 2 DiabetesPHASE2 COMPLETED -Mar 1, 2001 -Aug 9, 20061 Canada
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Study Endpoints
Primary Endpoints
Hemoglobin A1c
Secondary Endpoints
Efficacy - major and emerging risk factors for cardiovascular disease (blood pressure, Hs-C-reactive protein, coagulation factors)
safety (liver, kidney and haemostatic function)
compliance (plasma fatty-acids, returned supplements, diet records, body weight).
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
Salba dietBEHAVIORAL -
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Eligibility Criteria
Age Range35 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * All men or postmenopausal women with Type 2 diabetes optimally or suboptimally controlled (HbA1C \< 9.0%) on oral hypoglycemic agents or diet only were asked to participate. Exclusion Criteria: * Those receiving insulin, alpha-glucosidase inhibitors, or hormone replacement t...

Countries:Canada
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