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TTP399

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |vTv Therapeutics Inc.|Last Updated: Feb 10, 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 Enrollment190
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02405260Add Glucokinase Activator to Target A1cPHASE2 COMPLETED 190Mar 1, 2015Sep 1, 2016Feb 10, 201720 United States
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Study Endpoints
Primary Endpoints
Change in HbA1c (Glycosylated haemoglobin)
Day 1 to Day 168
Secondary Endpoints
HbA1c < 7% at 6 months
Day 1 to Day 168
HbA1c < 6.5% at 6 months
Day 1 to Day 168
Plasma Glucose Levels
Day 1 to Day 168
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TTP399 400 mgEXPERIMENTALTTP399 once daily
TTP399 800 mgEXPERIMENTALTTP399 once daily
Sitagliptin 100 mgACTIVE_COMPARATORSitagliptin once daily
PlaceboPLACEBO_COMPARATORPlacebo once daily
Interventions
NameTypeDescription
TTP399 400 mgDRUGonce daily
TTP399 800 mgDRUGonce daily
Sitagliptin 100 mgDRUGonce daily
PlaceboDRUGonce daily
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * A historical diagnosis of Type 2 Diabetes in accordance with the American Diabetes Association (ADA) guidelines, with diagnosis at least 6 months prior to Screening. * On a stable (for the last 3 months prior to screening) regimen of metformin monotherapy equivalent of at leas...

Countries:United States
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