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TAK-559

Phase 3

Diabetes Mellitus | Small molecule | Metabolic |Takeda Pharmaceutical Company Limited|Last Updated: Nov 12, 2012

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 Enrollment302
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00763022Efficacy of TAK-559 in Treating Subjects With Type 2 Diabetes MellitusPHASE3 COMPLETED 302 — — Nov 1, 2003Dec 1, 2004Nov 12, 2012 - —
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Study Endpoints
Primary Endpoints
Change in Baseline in Glycosylated hemoglobin.
Weeks: 4, 8, 12, 16, 20 and Final Visit.
Secondary Endpoints
Change in Baseline in Glycosylated hemoglobin.
Weeks: 4, 8, 12, 16, 20 and Final Visit.
Change in Baseline in Fasting Plasma Glucose.
Weeks: 2, 4, 8, 12, 16, 20 and Final Visit.
Change in Baseline in Serum insulin.
Weeks: 4, 12, 16, 20 and Final Visit.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TAK-559 16 mg QDEXPERIMENTAL -
TAK-559 32mg QDEXPERIMENTAL -
Placebo QDPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
TAK-559DRUGTAK-559 16 mg, tablets, orally, once daily for up to 26 weeks.
PlaceboDRUGTAK-559 placebo-matching tablets, orally, once daily for up to 26 weeks.
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Eligibility Criteria
Age Range25 Years — 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Is diagnosed with type 2 diabetes mellitus using American Diabetes Association diagnostic criteria, and on a stable dose of an oral anti-diabetic monotherapy prior to Screening A. * Had a glycosylated hemoglobin level greater than or equal to 8.0% and less than or equal to 10....

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