Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia

Type 2 Diabetes Clinical Trial

— BANTING  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02739984
• Other study ID #: 20130287
• Secondary ID: 2015-004711-21
• Status: Completed
• Phase: Phase 3
• Start date: May 17, 2016
• Est. completion date: August 3, 2017

Study information

• Verified date: August 2018
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: August 3, 2017
• Est. primary completion date: August 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Dyslipidemias
• Hypercholesterolemia
• Mixed Dyslipidemia
• Type 2 Diabetes

Intervention

Biological:
• Evolocumab
Administered by subcutaneous injection with an automated mini doser

Drug:
• Placebo to Evolocumab
Administered by subcutaneous injection with an automated mini doser

Locations

Country	Name	City	State
Belgium	Research Site	Edegem
Belgium	Research Site	Leuven
Belgium	Research Site	Liege
Canada	Research Site	Gatineau	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	St-Jérôme	Quebec
Canada	Research Site	Vancouver	British Columbia
Italy	Research Site	Roma
Italy	Research Site	Roma
Italy	Research Site	Verona
Mexico	Research Site	Chihuahua
Mexico	Research Site	Guadalajara	Jalisco
Poland	Research Site	Katowice
Poland	Research Site	Krakow
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Spain	Research Site	Almeria	Andalucía
Spain	Research Site	Badalona	Cataluña
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Granada	Andalucía
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Auburn	Maine
United States	Research Site	Austin	Texas
United States	Research Site	Bay City	Michigan
United States	Research Site	Boca Raton	Florida
United States	Research Site	Chicago	Illinois
United States	Research Site	Chicago	Illinois
United States	Research Site	Chicago	Illinois
United States	Research Site	Columbus	Ohio
United States	Research Site	Coral Gables	Florida
United States	Research Site	Daytona Beach	Florida
United States	Research Site	Denver	Colorado
United States	Research Site	Dunwoody	Georgia
United States	Research Site	Fleming Island	Florida
United States	Research Site	Hollywood	Florida
United States	Research Site	Houston	Texas
United States	Research Site	Inverness	Florida
United States	Research Site	Jacksonville	Florida
United States	Research Site	Lakewood	Colorado
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lomita	California
United States	Research Site	Los Angeles	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Meridian	Idaho
United States	Research Site	Methuen	Massachusetts
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	New Windsor	New York
United States	Research Site	New York	New York
United States	Research Site	New York	New York
United States	Research Site	Norman	Oklahoma
United States	Research Site	Phoenix	Arizona
United States	Research Site	Roseville	California
United States	Research Site	Salisbury	Maryland
United States	Research Site	San Ramon	California
United States	Research Site	Scarborough	Maine
United States	Research Site	Shelby	North Carolina
United States	Research Site	Spring Valley	California
United States	Research Site	Suffolk	Virginia
United States	Research Site	Tabor City	North Carolina
United States	Research Site	Tarzana	California
United States	Research Site	Tupelo	Mississippi
United States	Research Site	Tuscumbia	Alabama
United States	Research Site	Walnut Creek	California
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Italy,  Mexico,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12		Baseline and Weeks 10 and 12
Primary	Percent Change From Baseline in LDL-C at Week 12		Baseline and week 12
Secondary	Change From Baseline in LDL-C at the Mean of Weeks 10 and 12		Baseline and weeks 10 and 12
Secondary	Change From Baseline in LDL-C at Week 12		Baseline and week 12
Secondary	Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12		Baseline and weeks 10 and 12
Secondary	Percent Change From Baseline in Non-HDL-C at Week 12		Baseline and week 12
Secondary	Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12		Baseline and weeks 10 and 12
Secondary	Percent Change From Baseline in Apolipoprotein B at Week 12		Baseline and week 12
Secondary	Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12		Baseline and weeks 10 and 12
Secondary	Percent Change From Baseline in Total Cholesterol at Week 12		Baseline and week 12
Secondary	Percentage of Participants With Mean LDL-C at Weeks 10 and 12 Less Than 70 mg/dL (1.8 mmol/L)		Weeks 10 and 12
Secondary	Percentage of Participants With LDL-C at Week 12 Less Than 70 mg/dL (1.8 mmol/L)		Week 12
Secondary	Percentage of Participants With at Least a 50% Reduction From Baseline in Mean LDL-C at Weeks 10 and 12		Baseline and weeks 10 and 12
Secondary	Percentage of Participants With at Least a 50% Reduction From Baseline in LDL-C at Week 12		Baseline and Week 12
Secondary	Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12		Baseline and weeks 10 and 12
Secondary	Percent Change From Baseline in Lipoprotein(a) at Week 12		Baseline and week 12
Secondary	Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12		Baseline and weeks 10 and 12
Secondary	Percent Change From Baseline in Triglycerides at Week 12		Baseline and week 12
Secondary	Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12		Baseline and weeks 10 and 12
Secondary	Percent Change From Baseline in HDL-C at Week 12		Baseline and week 12
Secondary	Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12		Baseline and weeks 10 and 12
Secondary	Percent Change From Baseline in VLDL-C at Week 12		Baseline and week 12

External Links

•   AmgenTrials clinical trials website