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Vildagliptin AM

Phase 3

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Novartis AG|Last Updated: Nov 18, 2016

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 Enrollment370
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00351884Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin in Patients With Type 2 DiabetesPHASE3 COMPLETED 370 — — May 1, 2006 -Nov 18, 20162 United States, Germany
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Study Endpoints
Primary Endpoints
Change from baseline in HbA1c at 24 weeks
24 weeks
Secondary Endpoints
Safety of vildagliptin in combination with metformin during 24 weeks of treatment
24 weeks
Change from baseline in fasting plasma glucose at 24 weeks
24 weeks
Patients with endpoint HbA1c < 7% after 24 weeks
24 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
vildagliptin amEXPERIMENTAL -
vildagliptin pmEXPERIMENTAL -
placeboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Vildagliptin AMDRUG -
vildagliptin pmDRUG -
placeboDRUG -
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Eligibility Criteria
Age Range18 Years — 78 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Patients on metformin for at least three months and on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1 * Body mass index in the range 22-40 * Blood glucose criteria must be met Exclusion Criteria: * Pregnancy or lactation * History of type 1...

Countries:United StatesGermany
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