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vildagliptin

Phase 3

Type-2 Diabetes | 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 Trials2
Total Enrollment159
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00651105Effect of LAF237 on Glucagon Secretion in Patients With Type 2 Diabetes and in Healthy SubjectsPHASE3 COMPLETED 63Feb 1, 2008 -Nov 18, 20162 Germany
NCT00567047Pharmacokinetic Study of Vildagliptin in Patients With Renal ImpairmentPHASE1 COMPLETED 96Jul 1, 2007 -Mar 25, 20096 United States, Germany
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Study Endpoints
Primary Endpoints
GLP-1 and non GLP-1 effects of LAF237 on glucagon secretion in patients with Type-2 diabetes and matching healthy subjects
from baseline to Day 10
• Pharmacokinetic measures
throughout the study
Secondary Endpoints
Effects of LAF237 on prandial glucose profiles, prandial insulin, and gastric-emptying in patients with Type-2 diabetes and in matching healthy subjects.
10 day treatment periods
• Safety and tolerability measures
throughout the study
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
VildagliptinDRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range30 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: Inclusion criteria - Type-2 Diabetes Patients * Male or female patients aged 30 to 75 years with Type-2 Diabetes Mellitus (T2DM) and who are in otherwise good health * Must have been diagnosed with T2DM at least 6 months prior to screening, and whose diabetes is controlled by d...

Countries:GermanyUnited States
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