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BMS-512148

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Oct 27, 2016

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 Enrollment47
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00162305A Phase IIA Study of BMS-512148 to Assess Safety, Exposure, and Biological Effects in Stable Type 2 Diabetic SubjectsPHASE2 COMPLETED 47 — — Apr 1, 2005Aug 1, 2005Oct 27, 20165 United States
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Study Endpoints
Primary Endpoints
To assess the safety and tolerability of multiple oral doses of BMS-512148 administered alone or concomitantly with metformin in diabetic subjects
14 days

Adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments

Secondary Endpoints
To assess the PK of BMS-512148 and its pharmacologically active metabolite, BMS-511926, when BMS-512148 is administered alone or concomitantly with metformin
14 days
To assess the pharmacodynamic effect of BMS-512148, administered alone or concomitantly with metformin, on serum and urine markers of glucose homeostasis
14 days
To assess the effect of BMS-512148, administered alone or concomitantly with metformin, on safety markers in urine
14 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATOR -
2ACTIVE_COMPARATOR -
3ACTIVE_COMPARATOR -
4PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
BMS-512148DRUGCapsules, Oral, 100 mg, Once daily, 14 days.
PlaceboDRUGCapsules, Oral, 0 mg, Once daily, 14 days.
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Established diagnosis of Type 2 diabetes mellitus, who are treated with metformin or diet alone (drug naive). * Fasting glucose (FG) \< - 240 mg/dL, while on metformin or antidiabetic diet alone. * HbA1c (Hemoglobin A1c) in the range of 6.0-10.0% Exclusion Criteria: * Women ...

Countries:United States
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