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BMS-770767

Phase 2

Diabetes Type 2 | Small molecule | Metabolic |Bristol-Myers Squibb Company|Last Updated: Oct 12, 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 Enrollment76
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01046422Safety Study of BMS-770767 in Subjects With Type 2 DiabetesPHASE2 COMPLETED 76May 1, 2010Jan 1, 2011Oct 12, 201518 United States, Australia +2
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Study Endpoints
Primary Endpoints
Fasting Plasma Glucose Improvement
Within seven days following dosing
Secondary Endpoints
Mean daily glucose (3-day 7 pt-fingerstick)
Within 28 days following dosing
Four (4)-hour post-prandial glucose AUC
Within 28 days following dosing
HbA1C
Within 28 days following dosing
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BMS-770767 ± metformin (Treatment A)EXPERIMENTAL -
BMS-770767 ± metformin (Treatment B)EXPERIMENTAL -
BMS-770767 ± metformin (Treatment C)EXPERIMENTAL -
BMS-770767 ± metformin (Treatment D)EXPERIMENTAL -
Placebo ± metformin (Treatment E)PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
BMS-770767DRUGCapsule, Oral, 15mg, Active, Daily, 28 days
PlaceboDRUGCapsule, Oral, 0mg, Daily, 28 days
MetforminDRUGTablet, Oral, ≥ 1500mg, Active, Daily, 28 days
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Diagnosed with type 2 diabetes with inadequate glycemic control and treated with either diet and exercise alone, or with stable doses (≥ 1500mg/d) of metformin for at least 8 weeks prior to screening * HbA1c ≥ 7.0% and ≤ 10.0% with FPG ≤ 240mg/dL (13.3 mmol/dL) Exclusion Crit...

Countries:United StatesAustraliaCanadaSouth Korea
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