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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
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
RandomizedPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01324921Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 DiabeticsPHASE2 COMPLETED 37Aug 1, 2010Sep 1, 2010Mar 30, 20112 United States
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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 — 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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