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Whole cooked beans with rice meals

Phase 2

Blood Glucose | Unknown | Metabolic |United Therapeutics Corporation|Last Updated: Oct 31, 2019

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
RandomizedNO_TREATMENT_CONTROLLEDBiomarker
Total Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01241253Glycemic Response of Bean-and-rice Meals in Type 2 Diabetes MellitusPHASE2 COMPLETED 17Nov 1, 2009Apr 1, 2010Oct 31, 20191 United States
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Study Endpoints
Primary Endpoints
Net blood glucose changes over time
fasting baseline glucose at time 0, then 30, 60, 90, 120, 150, and 180 minutes postprandial

Capillary blood samples were collected via fingerstick using Safe-T-Fill® Lithium Heparin Mini Capillary Collection 125µl tubes (RAM Scientific, Yonkers, NY). Whole blood samples were analyzed for glucose content using the Yellow Springs Instrument Stat Plus Analyzer (YSI Life Sciences, Yellow Springs, OH) immediately after blood collection.

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Cross-over studyNO_INTERVENTIONbeans and rice in a 50 gram carbohydrate dose
Interventions
NameTypeDescription
Whole cooked beans with rice mealsOTHERThree types of bean-and-rice meals all equal to 50 grams available CHO. Control treatment was 50 grams available CHO in the form of white rice alone.
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Eligibility Criteria
Age Range35 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Eligible subjects will be between the ages of 35 and 75, have a body mass index value (BMI) between 22-40 kg/m2, be physician diagnosed with type 2 diabetes for at least six (6) months and currently controlling their blood glucose levels using dietary methods, exercise and/or ...

Countries:United States
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