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No breakfast/beverage only, Breakfast, 10004RF

Phase 2

Diabetes Mellitus, Type 2 | Unknown | Metabolic |Abbott Laboratories|Last Updated: Mar 30, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

No breakfast/beverage only, Breakfast, 10004RF · 1 trial · 1 indication

Phase 2 1
NCT01324921Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 DiabeticsDiabetes Mellitus, Type 2
COMPLETED37 Analytics
PHASE2COMPLETED
Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetics
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Positive AUC for plasma glucose concentration
0 to 180 minutes

Secondary Endpoints

Plasma glucose concentrations
0 to 180 minutes
Positive AUC for serum insulin concentration
0-180 minutes
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
No breakfast/beverage onlyPLACEBO_COMPARATOR12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
BreakfastACTIVE_COMPARATOR1 serving of unflavored instant oatmeal and 12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
10004RFEXPERIMENTAL1 serving (8 fluid ounces) of the experimental beverage and 4 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener

Interventions

NameTypeDescription
No breakfast/beverage onlyOTHER12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
BreakfastOTHER1 serving of unflavored instant oatmeal and 12 fluid ounces made up of one of some combination of the following:decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
10004RFOTHER1 serving (8 fluid ounces) of the experimental beverage and 4 fluid ounces made up of one of some combination of the following:decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. type 2 diabetes 2. between 21 and 75 years of age 3. male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile 4. BMI is \> 18.5 kg/m2 and \<35 kg/m2 5. If subject is on a chronic medication such as an anti-hypertensive,...

Countries:United States
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Frequently asked questions about No breakfast/beverage only, Breakfast, 10004RF

What is 10004RF used for in Diabetes Mellitus, Type 2?

10004RF is an investigational nutritional product being studied for its effect on metabolic parameters in people with Type 2 Diabetes Mellitus. It is being developed by Abbott Laboratories and is currently in Phase 2 clinical development. The product is intended for use in adults aged 18 years and older.

Who makes 10004RF?

Abbott Laboratories (NYSE: ABT) is developing 10004RF. The company is conducting clinical research to evaluate the product's effect on metabolic parameters in subjects with Type 2 Diabetes Mellitus. The product is currently in Phase 2 development and is not yet approved for commercial use.

What phase is 10004RF in?

10004RF is in Phase 2 clinical development. It is an investigational product being studied for Type 2 Diabetes Mellitus. The product has completed one Phase 2 trial and is not yet approved by regulatory authorities. It remains under clinical investigation to assess its effects on metabolic parameters.

What clinical trials is 10004RF in?

10004RF has been studied in one completed clinical trial, NCT01324921, titled 'Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetics.' This Phase 2 trial enrolled 37 participants in the United States and was placebo-controlled. The study included adults aged 18 years and older with Type 2 Diabetes Mellitus.

Is 10004RF the same as a breakfast or beverage product?

10004RF is a nutritional product being studied in the context of meal consumption. The clinical trial NCT01324921 evaluated the product's effect on metabolic parameters in subjects with Type 2 Diabetes Mellitus. The product is being developed by Abbott Laboratories and is currently in Phase 2 clinical development.