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Muraglitazar

Phase 3

Metabolics Diabetes Nos | Small molecule | Metabolic |Bristol-Myers Squibb Company|Last Updated: Sep 14, 2010

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 Enrollment534
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00162175PPAR-COMBO With SulfonylureaPHASE3 COMPLETED 534 — — Jul 1, 2003Nov 1, 2005Sep 14, 2010149 United States, Argentina +13
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Study Endpoints
Primary Endpoints
Compare change from baseline in HbA1c after 24 weeks of treatment with muraglitazar + glyburide vs placebo + glyburide
Secondary Endpoints
Change in FPG from basline to W24, proportion of subjects receiving therapeutic response at W24, percent change of fasting lipid levels from baseline to W11/12, change in hs-CRP from baseline to W24
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
MuraglitazarDRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites149

Inclusion Criteria: * Type 2 Diabetes, HbA1c \> 7.0% and \< 10.0%, mean serum triglyceride \< 600 mg/dL, body mass index \< 41 kg/m2, fasting c-peptide . 1.5 ng/mL. Exclusion Criteria: * History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, un...

Countries:United StatesArgentinaAustraliaBrazilCanadaFranceGermanyItalyMexicoNetherlandsPeruPuerto RicoRussiaSpainUnited Kingdom
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