NCT02662569

Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety and Efficacy of Evolocumab (AMG 145) in Combination With Statin Therapy in Diabetic Subjects With Hyperlipidemia or Mixed Dyslipidemia (BERSON)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 986 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) in combination with statin therapy (atorvastatin) on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in diabetic adults with hyperlipidemia or mixed dyslipidemia.

Conditions

• Diabetes, Hyperlipidemia, Mixed Dyslipidemia

Interventions

Type	Name	Description
BIOLOGICAL	Evolocumab	Administered by subcutaneous injection
DRUG	Atorvastatin	Administered orally once a day
OTHER	Placebo	Placebo to evolocumab administered by subcutaneous injection

Timeline

• Start date: 2016-04-14
• Primary completion: 2017-12-06
• Completion: 2017-12-06
• First posted: 2016-01-25
• Last updated: 2019-01-11
• Results posted: 2019-01-11

Locations

110 sites across 10 countries: United States, Argentina, Brazil, Canada, China, Colombia, France, Russia, South Korea, Turkey (Türkiye)