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Avandamet

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment544

FDA Designations

No designations recorded

Clinical trial landscape

Avandamet · 1 trial · 1 indication

Phase 3 1
NCT00359112AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 DiabetesNon-Insulin-Dependent Diabetes Mellitus
COMPLETED544 Analytics
PHASE3COMPLETED
AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes
Non-Insulin-Dependent Diabetes Mellitus
NCT00359112544
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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 to 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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