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PF-00734200

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Jun 27, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment592
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00618007Effect of PF-00734200 in Subjects With Type 2 DiabetesPHASE2 COMPLETED 289 — — Feb 1, 2008Aug 1, 2008Jun 27, 201179 United States, Canada +2
NCT0047352512 Week Study Of PF-00734200 For The Treatment Of Type 2 Diabetes Mellitus In Subjects Treated With MetforminPHASE2 COMPLETED 303 — — Jul 1, 2007Jun 1, 2008Jun 24, 201079 United States, Colombia +4
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Study Endpoints
Primary Endpoints
HbA1c
12 weeks
HbA1C levels (%)
12 weeks
Evaluation of Dose Response in HbA1c (%)
12 weeks
Secondary Endpoints
Fasting Glucose
12 weeks
Fasting Insulin
12 weeks
Insulin and Glucose AUC following a mixed meal tolerance test
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
30 mg QDEXPERIMENTAL -
20 mg QDEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
PF-00734200 10 mg QDEXPERIMENTAL -
PF-00734200 20 mg QDEXPERIMENTAL -
PF-00734200 5 mg QDEXPERIMENTAL -
PF-00734200 2 mg QDEXPERIMENTAL -
Interventions
NameTypeDescription
PF-00734200 30 mg QDDRUG30 mg QD
PF-00734200 20 mg QDDRUG20 mg QD
PlaceboDRUGPlacebo
PF-00734200 10 mg QDDRUG10 mg QD
PF-00734200 5 mg QDDRUG5 mg QD
PF-00734200 2 mg QDDRUG2 mg QD
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites79

Inclusion Criteria: Men or women between 18-80 years of age with poorly controlled Type 2 diabetes Exclusion Criteria: Type 1 or secondary forms of diabetes Currently using insulin

Countries:United StatesCanadaPuerto RicoSouth KoreaColombiaGermanyItalySpainSweden
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