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

Status:	Completed
Conditions:	High Cholesterol
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - 80
Updated:	1/13/2019
Start Date:	April 14, 2016
End Date:	December 6, 2017

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)

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.

Inclusion Criteria:

- Males and females with type 2 diabetes (receiving pharmacologic treatment for at least
6 months or longer) with stable diabetes therapy

- Lipid-lowering therapy must be unchanged for at least 4 weeks or more

- Subjects receiving statin therapy at screening must have a fasting LDL-C of greater
than or equal to 100 mg/dL

- Subjects not receiving statin therapy at screening must have a fasting LDL-C of
greater than or equal to 130 mg/dL

Exclusion criteria:

- New York Heart Association (NYHA) class III or IV heart failure

- Uncontrolled cardiac arrhythmia

- Uncontrolled hypertension

- Type 1 diabetes or poorly controlled type 2 diabetes

- Uncontrolled hypothyroidism or hyperthyroidism.

We found this trial at

sites

Clinical Trial Facility in Miami Florida

Miami, Florida 33136

from

Miami, FL