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LCQ908A

Phase 2

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Novartis AG|Last Updated: Jan 9, 2013

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 Enrollment693
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00901979A 12 Week Study in Patients With Type 2 Diabetes Mellitus (T2DM)PHASE2 COMPLETED 693 — — Apr 1, 2009Jun 1, 2010Jan 9, 201367 United States, Canada +3
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Study Endpoints
Primary Endpoints
Effect of LCQ on measures of glucose control
12 weeks
Secondary Endpoints
Changes in body weight and related measures
12 weeks
Insulin sensitivity
12 weeks
Safety and tolerability
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LCQ908 Dose 1EXPERIMENTAL -
LCQ908 Dose 2EXPERIMENTAL -
LCQ908 Dose 3EXPERIMENTAL -
LCQ908 Dose 4EXPERIMENTAL -
LCQ908 Dose 5EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
SitagliptinACTIVE_COMPARATOR -
Interventions
NameTypeDescription
LCQ908ADRUG -
PlaceboDRUG -
SitagliptinDRUG -
metforminDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites67

Inclusion Criteria: * HbA1c from 7.0-10.0%, Stable Metformin dose Exclusion Criteria: * CHF Class III-IV, Liver disease Other protocol-defined inclusion/exclusion criteria may apply

Countries:United StatesCanadaItalyPolandPuerto Rico
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