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Phase 3

Diabetes Mellitus, Type 2 | Unknown | Metabolic |Pfizer, Inc.|Last Updated: Mar 19, 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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment740
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00139763US Inhaled Insulin Therapeutic Choice Questionnaire StudyPHASE3 COMPLETED 740 — — Jul 1, 2005Mar 1, 2006Mar 19, 200742 United States
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Study Endpoints
Primary Endpoints
Will availability of inhaled insulin result in more type 2 diabetes patients choosing a treatment that involves insulin (if now on >2 OAs) or a more intensive insulin regimen (if now on OAs + glargine) compared to only standard therapies available
Secondary Endpoints
Determine both patient and MD reasons for treatment choices made. Determine if treatment choice is influenced by physician specialty or patient ethnicity. Determine how cost impacts patient treatment choice.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeECT
Interventions
NameTypeDescription
Educational MaterialsPROCEDURE -
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites42

Inclusion Criteria: * Male and female, age \> = 18 years and \<= 80 years with a diagnosis of type 2 diabetes made at least 6 months prior to study entry * Currently treated with either: * 2 or more oral antidiabetic agents, OR 1 or more oral antidiabetic agents and insulin glargine Exclusion Crit...

Countries:United States
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