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PF-06291874

Phase 2

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Pfizer, Inc.|Last Updated: Aug 7, 2017

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 Trials1
Total Enrollment206
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02554877A 12-week Study To Evaluate PF-06291874 Once a Day in Adults With T2DM Inadequately Controlled On MetforminPHASE2 COMPLETED 206Oct 1, 2015Aug 1, 2016Aug 7, 201738 United States, Canada
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Study Endpoints
Primary Endpoints
Change From Baseline in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 as Compared to Placebo
Baseline, Week 12

HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Baseline was defined as the last pre-dose measurement prior to first double blind dosing for the study.

Secondary Endpoints
Change From Baseline in HbA1c (%) at Weeks 2, 4, and 8
Baseline, Weeks 2, 4, 8
Change From Baseline in Fasting Plasma Glucose at Weeks 2, 4, 8, and 12
Baseline, Weeks 2,4,8 and 12
Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) <7% as Well as <6.5% at Week 12.
Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
PF-06291874, 30 mgEXPERIMENTAL -
PF-06291874, 60 mgEXPERIMENTAL -
PF-06291874, 100 mgEXPERIMENTAL -
Interventions
NameTypeDescription
PF-06291874DRUGstudy drug to be given as an oral tablet at 30, 60 or 100 mg
PlaceboDRUGoral tablet
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: 1. Males or non-childbearing potential females between the ages of 18 (or the minimum country specific age of consent if \>18) and 70 years, inclusive, at the screening visit (V1) with the diagnosis of T2DM;Female subjects who are not of childbearing potential 2. Subjects who ha...

Countries:United StatesCanada
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