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Sulphonylurea

Phase 3

Type 2 Diabetes | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Mar 21, 2012

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment891

FDA Designations

No designations recorded

Clinical trial landscape

Sulphonylurea · 1 trial · 1 indication

Phase 3 1
NCT0057558852-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension PeriodType 2 Diabetes
COMPLETED891 Analytics
PHASE3COMPLETED
52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period
Type 2 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Hemoglobin A1c (HbA1c) Change From Baseline to Week 52
Baseline to 52 Weeks

Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value.

Secondary Endpoints

Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks
From Baseline to Week 52
Body Weight Change From Baseline to Week 52
Baseline, Week 52 (Last Observation Carried Forward)
Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c
Week 24 to Week 52
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SaxagliptinEXPERIMENTAL -
GlipizideEXPERIMENTAL -

Interventions

NameTypeDescription
MetforminDRUGopen-label metformin
SulphonylureaDRUGGlipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)
SaxagliptinDRUGSaxagliptin 5 mg tablets
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites94

Inclusion Criteria: * Diagnosed with type 2 diabetes, * Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks prior to Visit 1, * HbA1c \>6.5% and ≤10.0% Exclusion Criteria: * Type 1 diabetes, * history of diabetic ketoacidosis or hyperosmolar non-ketoni...

Countries:FinlandGermanyHungaryIndiaNetherlandsNorwayRussiaSlovakiaSouth KoreaUnited KingdomVietnam
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Frequently asked questions about Sulphonylurea

What is Sulphonylurea used for in Type 2 Diabetes?

Sulphonylurea is an investigational small molecule being studied for the treatment of Type 2 Diabetes. It is currently in Phase 3 clinical development, though no approval has been granted. The drug is being evaluated as an add-on therapy to metformin in a completed clinical trial.

What does Sulphonylurea target?

Sulphonylurea targets the sulfonylurea receptor, a class of drugs that stimulate insulin release from pancreatic beta cells. This mechanism helps lower blood glucose levels in patients with Type 2 Diabetes. The drug is being developed as a small molecule therapy.

Who makes Sulphonylurea?

Sulphonylurea is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 2 Diabetes.

What phase is Sulphonylurea in?

Sulphonylurea is in Phase 3 clinical development. The drug is investigational and has not been approved by regulatory authorities. A Phase 3 trial has been completed, but the drug remains under investigation for the treatment of Type 2 Diabetes.

What clinical trials is Sulphonylurea in?

Sulphonylurea has one completed Phase 3 clinical trial with the identifier NCT00575588. This trial was a 52-week add-on to metformin study comparing saxagliptin and sulphonylurea, with a 52-week extension period. The trial enrolled 891 participants across multiple countries.

Is Sulphonylurea the same as Saxagliptin?

No, Sulphonylurea is not the same as Saxagliptin. In the clinical trial NCT00575588, saxagliptin and sulphonylurea were compared as separate add-on treatments to metformin in patients with Type 2 Diabetes. Sulphonylurea is a distinct drug candidate being developed by AstraZeneca.