Recent Updates
Recently added Catalysts

AMG 151

Phase 2

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment236

FDA Designations

No designations recorded

Clinical trial landscape

AMG 151 · 1 trial · 1 indication

Phase 2 1
NCT01464437AMG 151 Amgen Protocol Number 20100761Diabetes Mellitus
COMPLETED236 Analytics
PHASE2COMPLETED
AMG 151 Amgen Protocol Number 20100761
Diabetes Mellitus
NCT01464437236
Unlock trial analytics

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.
Unlock Study Endpoints

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.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about AMG 151

What is AMG 151 used for?

AMG 151 is an investigational small molecule being developed for the treatment of Diabetes Mellitus. It is currently in Phase 2 clinical development and has been studied in a completed trial involving 236 participants.

Who makes AMG 151?

AMG 151 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The drug is an investigational small molecule in Phase 2 clinical development for Diabetes Mellitus.

What phase is AMG 151 in?

AMG 151 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug is being studied for the treatment of Diabetes Mellitus.

What clinical trials is AMG 151 in?

AMG 151 has been studied in one completed Phase 2 clinical trial, identified as NCT01464437, with the title 'AMG 151 Amgen Protocol Number 20100761'. This trial enrolled 236 participants with Diabetes Mellitus and was conducted in the United States, Czechia, Estonia, Poland, and Puerto Rico.

Is AMG 151 FDA approved?

AMG 151 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Diabetes Mellitus. The drug has completed one Phase 2 trial, but it has not yet received regulatory approval.