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

• Status: Completed
• Trial end date: 2017-12-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Atorvastatin; Atorvastatin Calcium; Evolocumab

Criteria

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.