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Adult enteral formula

Phase 3

Diabetes Mellitus Type 2 | Unknown | Metabolic |Abbott Laboratories|Last Updated: Oct 15, 2007

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00540488Glucose/Insulin Responses:Subjects With Type 2 Diabetes Consuming Diabetes-Specific vs Standard Nutritional FormulasPHASE3 COMPLETED 54 — — Aug 1, 2002 -Oct 15, 20072 United States
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Study Endpoints
Primary Endpoints
Adjusted area under the curve (adj-AUC) of glucose response
0-240 minutes
Secondary Endpoints
Adjusted peak for glucose and insulin response;peak time for glucose and insulin response; Adj-AUC for insulin response; change in glucose and insulin; subjective gastrointestinal tolerance
0 - 240 minutes
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
Adult enteral formulaOTHER -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * signed and dated informed consent * 18-75 years of age * history of type 2 diabetes * males and non-pregnant, non-lactating females Exclusion Criteria: * subject uses insulin for glucose control * significant cardiovascular event \<12 weeks prior to study entry * active mali...

Countries:United States
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