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CCR2 Antagonist

Phase 2

Type 2 Diabetes | 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_CONTROLLED
Total Trials1
Total Enrollment58
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00699790Proof of Confidence Study of CCR2 Antagonist (BMS-741672) in Insulin ResistancePHASE2 COMPLETED 58Feb 1, 2009Dec 1, 2009Oct 12, 201512 Russia
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Study Endpoints
Primary Endpoints
Change in HbA1c
after 12 weeks of treatment
Secondary Endpoints
Other glycemic, atherosclerosis, lipid and mechanism-based biomarkers will be measured
throughout the 12 weeks of treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
A1EXPERIMENTAL -
A2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
CCR2 AntagonistDRUGTablets, Oral, 50 mg, once daily, 12 weeks
PlaceboDRUGTablets, Oral, 0mg, once daily, 12 weeks
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Drug-naive Type 2 diabetics with a screening HbA1c of ≥ 7.5% and ≤ 10% * Screening FPG ≥ 140 mg/dL and ≤ 220 mg/dL * BMI ≤ 40 kg/m2 Exclusion Criteria: * Active tuberculosis * Symptoms of poorly controlled diabetes * History of diabetic ketoacidosis * Significant cardiovascu...

Countries:Russia
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