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AVE2268

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment317
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00361738Dose-Ranging Study Evaluating AVE2268 in Patients With Type 2 Diabetes Not Adequately Controlled by a Metformin TreatmentPHASE2 COMPLETED 317 — — Jul 1, 2006Jan 1, 2008Feb 9, 200911 Argentina, Australia +9
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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 — 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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