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LY2393910

Phase 1

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Jun 10, 2011

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 Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01253278A Multiple-Ascending Dose Study in Type 2 Diabetes Mellitus PatientsPHASE1 COMPLETED 38Mar 1, 2010May 1, 2011Jun 10, 20111 Germany
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Study Endpoints
Primary Endpoints
Number of Participants with Clinically Significant Effects
Over four weeks
Secondary Endpoints
Pharmacokinetics of LY2393910, Area Under the Curve (AUC)
From predose Day 1 up until Day 19
Change from baseline to day 28 in glucagon
Baseline, day 28
Pharmacokinetics of LY2393910, maximum concentration (Cmax)
From predose Day 1 up until Day 19
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
20 mg LY2393910EXPERIMENTAL -
60 mg LY2393910EXPERIMENTAL -
150 mg LY2393910EXPERIMENTAL -
450 mg LY2393910EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
LY2393910DRUGas capsules, administered orally once daily for two weeks
PlaceboDRUGas capsules, administered orally once daily for two weeks
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Eligibility Criteria
Age Range21 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosis of type 2 diabetes mellitus * Must be on a stable treatment regimen (maintained on diet/exercise therapy with or without metformin) for at least 4 weeks prior to study entry * Have a glycated haemoglobin (HbA1c) value greater than or equal to 6.5% and less than or eq...

Countries:Germany
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