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AMG 151

Phase 2

Diabetes Mellitus | Small molecule | Metabolic |Amgen Inc.|Last Updated: May 13, 2014

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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment236
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01464437AMG 151 Amgen Protocol Number 20100761PHASE2 COMPLETED 236 — — Sep 1, 2011Dec 1, 2012May 13, 201477 United States, Czechia +3
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Study Endpoints
Primary Endpoints
To evaluate the dose-effect relationship of AMG 151 compared to placebo on fasting plasma glucose in subjects with type 2 diabetes treated with metformin
Change in fasting plasma glucose levels from baseline to Day 28
Secondary Endpoints
To assess the effect of AMG 151 on postprandial glucose levels in response to a meal tolerance test
Change in area under the curve from 0-4 hours (AUC0-4hr) glucose after a meal tolerancetest from baseline to Day 28, Change in incremental AUC0-4hr glucose after a meal tolerance test from baseline to Day 28
Adverse events
Incidence of serious adverse events from signing of ICF to Day 42. Incidence of non-serious adverse events from randomization to Day 42.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AMG 151 - Arm 1ACTIVE_COMPARATORAMG 151 - Arm 1
AMG 151 - Arm 2ACTIVE_COMPARATORAMG 151 - Arm 2
AMG 151 - Arm 3ACTIVE_COMPARATORAMG 151 - Arm 3
AMG 151 - Arm 4ACTIVE_COMPARATORAMG 151 - Arm 4
AMG 151 - Arm 5ACTIVE_COMPARATORAMG 151 - Arm 5
AMG 151 - Arm 6ACTIVE_COMPARATORAMG 151 - Arm 6
Placebo ArmPLACEBO_COMPARATORAMG 151 Placebo Arm
Interventions
NameTypeDescription
AMG 151DRUGDrug: AMG 151 50 mg BID
PlaceboDRUGPlacebo
MetforminDRUGSubjects will remain on their metformin regimen throughout the study. The metformin dose must be ≥ 850 mg/day for at least 2 months immediately prior to randomization.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites77

Inclusion Criteria: * Age 18 to 75 years, inclusive * Diagnosis of type 2 diabetes mellitus * HbA1c levels 7.5% to 11.0%, inclusive, at screening * Fasting C-peptide levels ≥ 0.2 nmol/L at screening * BMI ≥ 25 to \< 45 kg/m2 at screening * Treated with metformin monotherapy for at least 3 months pr...

Countries:United StatesCzechiaEstoniaPolandPuerto Rico
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