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AVE2268

Phase 2

Type 2 Diabetes Mellitus | Small molecule | Metabolic |Sanofi|Last Updated: Feb 9, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment317

FDA Designations

No designations recorded

Clinical trial landscape

AVE2268 · 1 trial · 1 indication

Phase 2 1
NCT00361738Dose-Ranging Study Evaluating AVE2268 in Patients With Type 2 Diabetes Not Adequately Controlled by a Metformin TreatmentType 2 Diabetes Mellitus
COMPLETED317 Analytics
PHASE2COMPLETED
Dose-Ranging Study Evaluating AVE2268 in Patients With Type 2 Diabetes Not Adequately Controlled by a Metformin Treatment
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Mean Plasma Glucose (MPG) from baseline to week 4.

Secondary Endpoints

Glucose parameters (change from baseline to week 4 in fasting and post prandial plasma glucose) ; Change in HbA1c and fructosamine ; Safety: physical examination, adverse events, ECG, laboratory tests
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
AVE2268DRUG -
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Eligibility Criteria

Age Range18 Years to 74 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Type 2 diabetes mellitus, as defined by the American Diabetes Association, for at least one year at the time of screening. * HbA1c measured at visit 1 in the range of ≥ 7.0 and \< 9.0 %. * Stable metformin treatment (dose ≥ 1.5g/day for at least 3 months prior to enrollment in...

Countries:ArgentinaAustraliaBelgiumChileDenmarkFranceGermanyItalyNetherlandsPolandSouth Africa
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Frequently asked questions about AVE2268

What is AVE2268 used for?

AVE2268 is an investigational small molecule being developed for Type 2 Diabetes Mellitus. It is intended for patients whose diabetes is not adequately controlled by metformin treatment. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes AVE2268?

AVE2268 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for the treatment of Type 2 Diabetes Mellitus.

What phase is AVE2268 in?

AVE2268 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The drug is being studied in patients with Type 2 Diabetes Mellitus who are not adequately controlled by metformin treatment.

What clinical trials is AVE2268 in?

AVE2268 has one completed Phase 2 clinical trial registered under NCT00361738. This was a dose-ranging study evaluating the drug in 317 patients with Type 2 Diabetes Mellitus not adequately controlled by metformin. The trial was conducted across multiple countries including Argentina, Australia, Belgium, Chile, Denmark, France, Germany, Italy, Netherlands, Poland, and South Africa.

Is AVE2268 FDA approved?

AVE2268 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Type 2 Diabetes Mellitus. The drug has not completed the clinical trial process required for regulatory approval, and its safety and efficacy have not been established for commercial use.