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MBX-102

Phase 2

Type 2 Diabetes | Small molecule | Metabolic |Gilead Sciences, Inc.|Last Updated: May 1, 2015

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment396
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00353587Safety and Efficacy Study of Metaglidasen in Type 2 Diabetes in Patients Suboptimally Controlled on InsulinPHASE2 COMPLETED 396May 1, 2006Nov 1, 2007May 1, 201567 United States, Argentina +2
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Study Endpoints
Primary Endpoints
Evaluate effects of MBX-102 administered orally at doses of 200, 400 and 600 mg daily for 16 weeks, on glucose control, as measured by HbA1c
Evaluate safety of MBX-102 with particular emphasis on endpoints of weight gain and edema
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MBX-102 200 mgEXPERIMENTALMBX-102 200 mg once daily for 16 weeks
MBX-102 400 mgEXPERIMENTALMBX-102 400 mg once daily for 16 weeks
MBX-102 600 mgEXPERIMENTALMBX-102 600 mg once daily for 16 weeks
Sugar PillPLACEBO_COMPARATORPlacebo comparator once daily for 16 weeks
ActosACTIVE_COMPARATORActos 30 mg once daily for 16 weeks
Interventions
NameTypeDescription
MBX-102DRUGMBX-102 200 mg once daily for 16 weeks
PlaceboDRUGMBX-102 Placebo once daily for 16 weeks
ActosDRUGActos 30 mg once daily for 16 weeks
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites67

Inclusion Criteria: * Type 2 diabetes (as described by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus24) treated with insulin alone (a stable dose of long and/or intermediate-acting insulin or pre-mixed insulin e.g., "70/30") ≥ 30 units/day for at least 3 months, but ...

Countries:United StatesArgentinaIndiaIsrael
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