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Amino Acid Drink Mixture, Glucose drink

Phase 2

Overweight | Unknown | Other |Abbott Laboratories|Last Updated: Nov 25, 2010

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00974831Glucose Tolerance in Healthy Overweight AdultsPHASE2 COMPLETED 24Jul 1, 2009Oct 1, 2009Nov 25, 20101 United States
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Study Endpoints
Primary Endpoints
The primary variable is the positive area under the curve from 0 to 180 minutes for plasma glucose.
0-180 minutes
Secondary Endpoints
Plasma glucose, insulin, C-peptide, free fatty acids, and glucagon concentration data over time
0-180 minutes
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AA DrinkEXPERIMENTALAmino Acid Drink Mixture
Glucose drinkPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Amino Acid Drink MixtureOTHER22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins
Glucose drinkOTHER22 oz consumed in 7 oz, 8oz, 7 oz increments 5 minutes apart over 15 mins
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Eligibility Criteria
Age Range20 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Fasting blood glucose level of ≥ 70mg/dL and ≤ 125 mg/dL. 2. Subject states that he/she does not have type 1 or 2 diabetes. 3. Subject is overweight as defined as waist circumference ≥ 101 cm (40 inches) male; ≥ 88 cm (35 inches) female. 4. Subject's BMI is ≥ 25 kg/m2. 5. Sub...

Countries:United States
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