NCT02739984

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 424 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia
• Mixed Dyslipidemia
• Type 2 Diabetes

Interventions

Type	Name	Description
BIOLOGICAL	Evolocumab	Administered by subcutaneous injection with an automated mini doser
DRUG	Placebo to Evolocumab	Administered by subcutaneous injection with an automated mini doser

Timeline

• Start date: 2016-05-17
• Primary completion: 2017-08-03
• Completion: 2017-08-03
• First posted: 2016-04-15
• Last updated: 2018-08-31
• Results posted: 2018-08-31

Locations

66 sites across 7 countries: United States, Belgium, Canada, Italy, Mexico, Poland, Spain