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sulphonylurea

Phase 3

Non-Insulin-Dependent Diabetes Mellitus | Small molecule | Metabolic |GSK plc|Last Updated: May 18, 2009

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment544
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00359112AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 DiabetesPHASE3 COMPLETED 544Feb 1, 2004 -May 18, 2009142 Belgium, France +9
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Study Endpoints
Primary Endpoints
Change in HbA1c level from baseline following 52 weeks of treatment.
Secondary Endpoints
Change in FPG (fasting plasma glucose)
insulin sensitivity
beta cell function
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
metforminDRUG -
sulphonylureaDRUG -
AvandametDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites142

Inclusion criteria: * Body mass index \> or = to 25 kg/m2. * HbA1c \> or =7% and \< or =10% at screening. * FPG \> or = 7.0mmol/L (126mg/dL) at visit 2. * Receiving at least 0.85g of metformin at constant dose(s) for at least 8 weeks prior to visit 1a. * Female subjects must be postmenopausal or us...

Countries:BelgiumFranceGermanyIrelandItalyLithuaniaMexicoNetherlandsSpainSwitzerlandUnited Kingdom
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