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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

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLEDBiomarker
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Clinical trial landscape

Whole cooked beans with rice meals · 1 trial · 2 indications

Phase 2 1
NCT01241253Glycemic Response of Bean-and-rice Meals in Type 2 Diabetes MellitusBlood Glucose
COMPLETED17 Analytics
PHASE2COMPLETED
Glycemic Response of Bean-and-rice Meals in Type 2 Diabetes Mellitus
Blood Glucose
NCT0124125317
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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 to 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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Frequently asked questions about Whole cooked beans with rice meals

What is Whole cooked beans with rice meals used for?

Whole cooked beans with rice meals is an investigational dietary intervention being studied for blood glucose management in people with type 2 diabetes mellitus. It is a metabolic therapeutic currently in Phase 2 clinical development, evaluated for its effect on glycemic response.

Who makes Whole cooked beans with rice meals?

Whole cooked beans with rice meals is being developed by United Therapeutics Corporation, a company traded under the ticker UTHR. The developer is conducting clinical research to assess the product's impact on blood glucose levels in patients with type 2 diabetes.

What phase is Whole cooked beans with rice meals in?

Whole cooked beans with rice meals is in Phase 2 clinical development. It is an investigational product, not yet approved, and is being studied for its effects on blood glucose in type 2 diabetes mellitus. One Phase 2 trial has been completed.

What clinical trials is Whole cooked beans with rice meals in?

Whole cooked beans with rice meals has one completed Phase 2 trial, NCT01241253, titled 'Glycemic Response of Bean-and-rice Meals in Type 2 Diabetes Mellitus.' This study enrolled 17 participants in the United States and examined blood glucose and type 2 diabetes mellitus outcomes.

Is Whole cooked beans with rice meals the same as bean-and-rice meals?

Whole cooked beans with rice meals is also referred to as bean-and-rice meals in clinical trial documentation. The completed Phase 2 study NCT01241253 uses the title 'Glycemic Response of Bean-and-rice Meals in Type 2 Diabetes Mellitus,' confirming the alternative name.