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sulphonylurea

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

sulphonylurea · 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 sulphonylurea

What is sulphonylurea used for?

Sulphonylurea is used for the treatment of non-insulin-dependent diabetes mellitus, also known as type 2 diabetes. It is a small molecule therapeutic being developed by GSK plc for this metabolic condition.

Who makes sulphonylurea?

Sulphonylurea is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is intended for the treatment of non-insulin-dependent diabetes mellitus.

What phase is sulphonylurea in?

Sulphonylurea is in Phase 3 clinical development. It is an investigational drug for non-insulin-dependent diabetes mellitus and has not been approved for marketing. One Phase 3 trial has been completed.

What clinical trials is sulphonylurea in?

Sulphonylurea has been studied in a Phase 3 clinical trial with the identifier NCT00359112. The trial, titled 'AVANDAMET Versus Metformin And Sulphonylurea In People With Poorly Controlled Type 2 Diabetes', enrolled 544 participants and has been completed.

Is sulphonylurea the same as AVANDAMET?

Sulphonylurea is not the same as AVANDAMET. The clinical trial NCT00359112 compared AVANDAMET against a combination of metformin and sulphonylurea, indicating that sulphonylurea is a separate treatment evaluated in the study.