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DHEP

Phase 3

Diabetes | Unknown | Metabolic |Johnson & Johnson|Last Updated: Feb 14, 2006

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment146
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00291590Diabetes Health Enhancement Program to Improve Health of People With DiabetesPHASE3 COMPLETED 146Jul 1, 2001Aug 1, 2003Feb 14, 20061 United States
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Study Endpoints
Primary Endpoints
Reduction in glycated hemoglobin levels
Secondary Endpoints
Improvement in health status and diabetes self-care practices
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeECT
Interventions
NameTypeDescription
DHEPBEHAVIORAL -
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Eligibility Criteria
Age Range40 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Insured under Medicaid (SSI) or dual enrolled under Medicaid and Medicare for at least one year * Diagnosed type 1 or type 2 diabetes for at least 1 year (\>1 inpatient or \>2 outpatients visits with ICD-9 codes 250.00-250.9x, or prescriptions for insulin and/or oral hyperglyc...

Countries:United States
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