Clinical trial NCT02739984: Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia
Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Evolocumab (AMG 145) on LDL-C in Subjects With Type 2 Diabetes Mellitus and Hypercholesterolemia/Mixed Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Mixed Dyslipidemia
Type 2 Diabetes
Keywords: diabetes
type 2 diabetes
high blood cholesterol
hypercholesterolemia
mixed dyslipidemia
high cholesterol
statin intolerant
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-04-15
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein cholesterol (LDL-C) in adults with type 2 diabetes mellitus and high blood cholesterol on a maximally tolerated oral dose of statin of at least moderate-intensity.

Detailed description: This study will enroll adults with type 2 diabetes mellitus and elevated LDL-C or non-high-density lipoprotein cholesterol (non-HDL-C) levels on a stable, maximally tolerated statin dose of at least moderate-intensity at signing of the informed consent; statin therapy must remain unchanged during screening and the remainder of the study.

Eligibility criteria: Inclusion Criteria:

* Male or female ≥ 18 years
* Type 2 Diabetes Mellitus
* Hemoglobin A1c \< 10%
* Stable diabetes therapy
* Must be on maximally tolerated dose of statin of at least moderate Intensity
* Fasting triglycerides ≤ 600 mg/dL
* Not at LDL-C or Non-HDL-C goal.

Exclusion Criteria:

* Moderate to severe renal dysfunction
* Uncontrolled hypertension
* Persistent active liver disease or hepatic dysfunction
* Has taken a cholesterylester transfer protein inhibitor in the last 12 months,
* Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft or stroke within 3 months prior to randomization

Primary outcomes:
measure: Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
timeFrame: Baseline and Weeks 10 and 12
measure: Percent Change From Baseline in LDL-C at Week 12
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
timeFrame: Baseline and weeks 10 and 12
measure: Change From Baseline in LDL-C at Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
timeFrame: Baseline and weeks 10 and 12
measure: Percent Change From Baseline in Non-HDL-C at Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
timeFrame: Baseline and weeks 10 and 12
measure: Percent Change From Baseline in Apolipoprotein B at Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12
timeFrame: Baseline and weeks 10 and 12
measure: Percent Change From Baseline in Total Cholesterol at Week 12
timeFrame: Baseline and week 12
measure: Percentage of Participants With Mean LDL-C at Weeks 10 and 12 Less Than 70 mg/dL (1.8 mmol/L)
timeFrame: Weeks 10 and 12
measure: Percentage of Participants With LDL-C at Week 12 Less Than 70 mg/dL (1.8 mmol/L)
timeFrame: Week 12
measure: Percentage of Participants With at Least a 50% Reduction From Baseline in Mean LDL-C at Weeks 10 and 12
timeFrame: Baseline and weeks 10 and 12
measure: Percentage of Participants With at Least a 50% Reduction From Baseline in LDL-C at Week 12
timeFrame: Baseline and Week 12
measure: Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
timeFrame: Baseline and weeks 10 and 12
measure: Percent Change From Baseline in Lipoprotein(a) at Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
timeFrame: Baseline and weeks 10 and 12
measure: Percent Change From Baseline in Triglycerides at Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
timeFrame: Baseline and weeks 10 and 12
measure: Percent Change From Baseline in HDL-C at Week 12
timeFrame: Baseline and week 12
measure: Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12
timeFrame: Baseline and weeks 10 and 12
measure: Percent Change From Baseline in VLDL-C at Week 12
timeFrame: Baseline and week 12
Other outcomes:
Locations:
city: Tuscumbia
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Lomita
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Roseville
country: United States
facility: Research Site
state: California
city: San Ramon
country: United States
facility: Research Site
state: California
city: Spring Valley
country: United States
facility: Research Site
state: California
city: Tarzana
country: United States
facility: Research Site
state: California
city: Walnut Creek
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Lakewood
country: United States
facility: Research Site
state: Colorado
city: Wilmington
country: United States
facility: Research Site
state: Delaware
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Coral Gables
country: United States
facility: Research Site
state: Florida
city: Daytona Beach
country: United States
facility: Research Site
state: Florida
city: Fleming Island
country: United States
facility: Research Site
state: Florida
city: Hollywood
country: United States
facility: Research Site
state: Florida
city: Inverness
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Dunwoody
country: United States
facility: Research Site
state: Georgia
city: Meridian
country: United States
facility: Research Site
state: Idaho
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Auburn
country: United States
facility: Research Site
state: Maine
city: Scarborough
country: United States
facility: Research Site
state: Maine
city: Salisbury
country: United States
facility: Research Site
state: Maryland
city: Methuen
country: United States
facility: Research Site
state: Massachusetts
city: Bay City
country: United States
facility: Research Site
state: Michigan
city: Tupelo
country: United States
facility: Research Site
state: Mississippi
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: New Windsor
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Shelby
country: United States
facility: Research Site
state: North Carolina
city: Tabor City
country: United States
facility: Research Site
state: North Carolina
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Norman
country: United States
facility: Research Site
state: Oklahoma
city: Austin
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Suffolk
country: United States
facility: Research Site
state: Virginia
city: Edegem
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Gatineau
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: St-Jérôme
country: Canada
facility: Research Site
state: Quebec
city: Roma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Verona
country: Italy
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Chihuahua
country: Mexico
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Almeria
country: Spain
facility: Research Site
state: Andalucía
city: Granada
country: Spain
facility: Research Site
state: Andalucía
city: Badalona
country: Spain
facility: Research Site
state: Cataluña
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Rosenson RS, Daviglus ML, Handelsman Y, Pozzilli P, Bays H, Monsalvo ML, Elliott-Davey M, Somaratne R, Reaven P. Efficacy and safety of evolocumab in individuals with type 2 diabetes mellitus: primary results of the randomised controlled BANTING study. Diabetologia. 2019 Jun;62(6):948-958. doi: 10.1007/s00125-019-4856-7. Epub 2019 Apr 5.