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exenatide

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |GSK plc|Last Updated: Jun 4, 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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00259896In-patient Study in Patients With Type 2 Diabetes MellitusPHASE1 COMPLETED 30Oct 1, 2005 -Jun 4, 2012 -
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Study Endpoints
Primary Endpoints
Pharmacodynamic measurements during 7 days of dosing.
Secondary Endpoints
Pharmacokinetic measurements during 7 days of dosing.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
exenatideDRUG -
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Eligibility Criteria
Age Range18 Years — 66 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * have type 2 diabetes mellitus that has been diagnosed for at least three months * must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea * must be willing to wash-out of these medications for 14 days ...

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