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Avandamet

Phase 4FDA approved 2002

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

Avandamet development status

FDA approval Oct 10, 2002
Approval holderSb Pharmco
ApplicationNDA021410
Highest phase Phase 4 (NCT00343395)
Phase scored for GSKPhase 3
Registered trials 265+ across 66 sponsors since Nov 2004

Avandamet target and mechanism

ModalitySmall molecule

Also known as metformin, sulphonylurea

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

Avandamet clinical trials

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 MellitusUnlock trial analytics

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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Frequently asked questions about Avandamet

What is Avandamet used for?

Avandamet is used for Non-Insulin-Dependent Diabetes Mellitus, also known as type 2 diabetes. It is a small molecule therapy developed by GSK plc for the metabolic therapeutic area. It has been studied in adults with poorly controlled type 2 diabetes.

Who makes Avandamet?

Avandamet is made by GSK plc, which trades under the ticker GSK. GSK is the developer of this small molecule therapy for Non-Insulin-Dependent Diabetes Mellitus.

What phase is Avandamet in?

Avandamet has been studied in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. It is an investigational therapy for Non-Insulin-Dependent Diabetes Mellitus.

What clinical trials is Avandamet in?

Avandamet has been evaluated in the Phase 3 trial NCT00359112, titled AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes. This completed trial enrolled 544 participants across Belgium, France, Germany, Ireland, Italy, Lithuania, Mexico, the Netherlands, Spain, Switzerland, and the United Kingdom.

Is Avandamet FDA approved?

Avandamet is an investigational therapy and has been studied in Phase 3 clinical development for Non-Insulin-Dependent Diabetes Mellitus. It is not described as approved in the available information.