Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia
Completed · Phase 3 · Has a placebo group
Conditions studied: Diabetes, Hyperlipidemia, Mixed Dyslipidemia
In brief
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.
Key facts
- Study ID
- NCT02662569
- Run by
- Amgen
- People needed
- 986
- Starts
- 2016-04-14
- Expected to finish
- 2017-12-06
- Last updated by the study team
- 2019-01-11
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Research Site — Atlanta, Georgia, United States
- Research Site — Indianapolis, Indiana, United States
- Research Site — Iowa City, Iowa, United States
- Research Site — Overland Park, Kansas, United States
- Research Site — Monroe, Louisiana, United States
- Research Site — St Louis, Missouri, United States
- Research Site — Columbus, Ohio, United States
- Research Site — Dayton, Ohio, United States
- Research Site — Dallas, Texas, United States
- Research Site — San Antonio, Texas, United States
- Research Site — CABA, Buenos Aires, Argentina
- Research Site — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Research Site — Mar del Plata, Buenos Aires, Argentina
- Research Site — Buenos Aires, Argentina
- Research Site — Córdoba, Argentina
- Research Site — Brasília, Federal District, Brazil
- Research Site — Goiânia, Goiás, Brazil
- Research Site — São Paulo, São Paulo, Brazil
- Research Site — Rio de Janeiro, Brazil
- Research Site — Winnipeg, Manitoba, Canada
- Research Site — Hamilton, Ontario, Canada
- Research Site — London, Ontario, Canada
- Research Site — Woodstock, Ontario, Canada
- Research Site — Laval, Quebec, Canada
- Research Site — Miami, Florida, United States
Full record on ClinicalTrials.gov
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