Diabetes, Hyperlipidemia, Mixed Dyslipidemia Clinical Trial
— BERSONOfficial title:
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)
| Verified date | January 2019 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 986 |
| Est. completion date | December 6, 2017 |
| Est. primary completion date | December 6, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Caba | Buenos Aires |
| Argentina | Research Site | Ciudad Autonoma de Buenos Aires | Buenos Aires |
| Argentina | Research Site | Córdoba | |
| Argentina | Research Site | Mar del Plata | Buenos Aires |
| Brazil | Research Site | Brasília | Distrito Federal |
| Brazil | Research Site | Goiania | Goiás |
| Brazil | Research Site | Rio De Janeiro | |
| Brazil | Research Site | Sao Paulo | São Paulo |
| Canada | Research Site | Hamilton | Ontario |
| Canada | Research Site | Laval | Quebec |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Sherbrooke | Quebec |
| Canada | Research Site | St Jean sur Richelieu | Quebec |
| Canada | Research Site | Winnipeg | Manitoba |
| Canada | Research Site | Woodstock | Ontario |
| China | Research Site | Baotou | Inner Mongolia |
| China | Research Site | Beijing | |
| China | Research Site | Beijing | |
| China | Research Site | Beijing | |
| China | Research Site | Beijing | Beijing |
| China | Research Site | Changchun | Jilin |
| China | Research Site | Changchun | Jilin |
| China | Research Site | ChangChun | Jilin |
| China | Research Site | Changsha | Hunan |
| China | Research Site | Changsha | Hunan |
| China | Research Site | Changsha | Hunan |
| China | Research Site | Chengdu | Sichuan |
| China | Research Site | Chongqing | Chongqing |
| China | Research Site | Guangzhou | Guangdong |
| China | Research Site | Guangzhou | Guangdong |
| China | Research Site | Guiyang | Guizhou |
| China | Research Site | Hangzhou | Zhejiang |
| China | Research Site | Hangzhou | Zhejiang |
| China | Research Site | Hangzhou | Zhejiang |
| China | Research Site | Hengyang | Hunan |
| China | Research Site | Jinan | Shandong |
| China | Research Site | Linhai | Zhejiang |
| China | Research Site | Nanchang | Jiangxi |
| China | Research Site | Nanjing | Jiangsu |
| China | Research Site | Nanjing | Jiangsu |
| China | Research Site | Nanjing | Jiangsu |
| China | Research Site | Nanjing | Jiangsu |
| China | Research Site | Nanning | Guangxi |
| China | Research Site | Shanghai | Shanghai |
| China | Research Site | Shanghai | |
| China | Research Site | Shanghai | |
| China | Research Site | Shanghai | |
| China | Research Site | Shanghai | |
| China | Research Site | Shenyang | Liaoning |
| China | Research Site | Shijiazhuang | Hebei |
| China | Research Site | Siping | Jilin |
| China | Research Site | Suzhou | Jiangsu |
| China | Research Site | Tianjin | Tianjin |
| China | Research Site | Urumqi | Xinjiang |
| China | Research Site | Wenzhou | Zhejiang |
| China | Research Site | Wuhan | Hubei |
| China | Research Site | Wuhan | Hubei |
| China | Research Site | Wuxi | Jiangsu |
| China | Research Site | XI An | Shaanxi |
| China | Research Site | Xuzhou | Jiangsu |
| China | Research Site | Zhenjiang | Jiangsu |
| China | Research Site | Zhuzhou | Hunan |
| Colombia | Research Site | Barranquilla | Atlántico |
| Colombia | Research Site | Barranquilla | Atlántico |
| Colombia | Research Site | Barranquilla | Atlántico |
| Colombia | Research Site | Medellin | Antioquia |
| Colombia | Research Site | Pasto | Nariño |
| France | Research Site | Dijon | |
| France | Research Site | Nantes Cedex 1 | |
| France | Research Site | Toulouse Cedex 9 | |
| Korea, Republic of | Research Site | Bucheon-si, Wonmi-gu | |
| Korea, Republic of | Research Site | Busan | |
| Korea, Republic of | Research Site | Busan | |
| Korea, Republic of | Research Site | Daegu | |
| Korea, Republic of | Research Site | Seongnam-si | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Russian Federation | Research Site | Kemerovo | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Saratov | |
| Russian Federation | Research Site | Tomsk | |
| Turkey | Research Site | Antalya | |
| Turkey | Research Site | Istanbul | |
| Turkey | Research Site | Istanbul | |
| Turkey | Research Site | Izmir | |
| Turkey | Research Site | Kocaeli | |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Dayton | Ohio |
| United States | Research Site | Indianapolis | Indiana |
| United States | Research Site | Iowa City | Iowa |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Monroe | Louisiana |
| United States | Research Site | Overland Park | Kansas |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | San Antonio | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States, Argentina, Brazil, Canada, China, Colombia, France, Korea, Republic of, Russian Federation, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | Baseline and weeks 10 and 12 | ||
| Primary | Percent Change From Baseline in LDL-C at Week 12 | Baseline and week 12 | ||
| Secondary | Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 | Baseline and weeks 10 and 12 | ||
| Secondary | Change From Baseline in LDL-C at Week 12 | Baseline and week 12 | ||
| Secondary | Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12 | Baseline and weeks 10 and 12 | ||
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 12 | Baseline and week 12 | ||
| Secondary | Percent Change From Baseline in Apolipoprotein B100 at the Mean of Weeks 10 and 12 | Baseline and weeks 10 and 12 | ||
| Secondary | Percent Change From Baseline in Apolipoprotein B100 at Week 12 | Baseline and week 12 | ||
| Secondary | Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12 | Baseline and weeks 10 and 12 | ||
| Secondary | Percent Change From Baseline in Total Cholesterol at Week 12 | Baseline and week 12 | ||
| Secondary | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 | Baseline and weeks 10 and 12 | ||
| Secondary | Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 | Baseline and week 12 | ||
| Secondary | Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 | Baseline and weeks 10 and 12 | ||
| Secondary | Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at Week 12 | Baseline and week 12 | ||
| Secondary | Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L) | Weeks 10 and 12 | ||
| Secondary | Percentage of Participants With LDL-C Less Than 70 mg/dL (1.8 mmol/L) at Week 12 | Week 12 | ||
| Secondary | Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 | Baseline and weeks 10 and 12 | ||
| Secondary | Percent Change From Baseline in Lipoprotein(a) at Week 12 | Baseline and week 12 | ||
| Secondary | Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 | Baseline and weeks 10 and 12 | ||
| Secondary | Percent Change From Baseline in Triglycerides at Week 12 | Baseline and week 12 | ||
| Secondary | Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 | Baseline and weeks 10 and 12 | ||
| Secondary | Percent Change From Baseline in HDL-C at Week 12 | Baseline and week 12 | ||
| Secondary | Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12 | Baseline and weeks 10 and 12 |