Back to Search Results
Study Complete
Sponsor ID
20120119

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

Sponsor ID
20120119
Clinicaltrials.gov ID
NCT02662569
EUCTIS ID
N/A
EudraCT ID
2013-000723-14
Contact Us

Study Details

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.

Additional Study Details

Phase
Phase 3
Product
Evolocumab
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
986
Additional Study Details

Protocol Summary

Primary Outcome Measures

Mean percent change from baseline in low density lipoprotein cholesterol (LDL-C)

Timeframe: weeks 10 and 12

Percent change from baseline in low density lipoprotein (LDL-C) at week 12

Timeframe: 12 weeks

Secondary Outcome Measures

Mean change from baseline in LDL-C

Timeframe: 10 and 12 weeks

Change from baseline in LDL-C

Timeframe: 12 weeks

Mean percent change from baseline in non-high density lipoprotein cholesterol

Timeframe: 10 and 12 weeks

Percent change from baseline in non-high density lipoprotein cholesterol

Timeframe: 12 weeks

Mean percent change from baseline in apolipoprotein B100

Timeframe: 10 and 12 weeks

Percent change from baseline in apolipoprotein B100

Timeframe: 12 weeks

Mean percent change from baseline in the total cholesterol

Timeframe: 10 and 12 weeks

Percent change from baseline in the total cholesterol

Timeframe: 12 weeks

Mean percent change from baseline in the total cholesterol/high density lipoprotein choleserol ratio

Timeframe: 10 and 12 weeks

Percent change from baseline in the total cholesterol/high density lipoprotein choleserol ratio

Timeframe: 12 weeks

Mean percent change from baseline in apolipoprotein B100/apolipoprotein A1 ratio

Timeframe: 10 and 12 weeks

Percent change from baseline in apolipoprotein B100/apolipoprotein A1 ratio

Timeframe: 12 weeks

Mean percent change from baseline in lipoprotein(a)

Timeframe: 10 and 12 weeks

Percent change from baseline in lipoprotein(a)

Timeframe: 12 weeks

Mean percent change from baseline in triglycerides

Timeframe: 10 and 12 weeks

Percent change from baseline in triglycerides

Timeframe: 12 weeks

Mean percent change from baseline in high density lipoprotein cholesterol

Timeframe: 10 and 12 weeks

Percent change from baseline in high density lipoprotein cholesterol

Timeframe: 12 weeks

Mean percent change from very low density lipoprotein cholesterol

Timeframe: 10 and 12 weeks

Percent change from very low density lipoprotein cholesterol

Timeframe: 12 weeks

Locations

Location
Status
Contact Us
Location
Research Site
Toulouse Cedex 9, France, 31059
Status
Recruiting
Location
Research Site
Brasília, Distrito Federal, Brazil, 71625-009
Status
Recruiting
Location
Research Site
Dijon, France, 21079
Status
Recruiting
Location
Research Site
Nantes Cedex 1, France, 44093
Status
Recruiting
Location
Research Site
Sao Paulo, São Paulo, Brazil, 01244-030
Status
Recruiting
Location
Research Site
Xi An, Shaanxi, China, 710061
Status
Recruiting
Showing {first} - {last} of {total} Results
Study Info
Age
18 - 80 Years
Condition
  • Diabetes
    • Sex
    All
    Trial Dates
    Apr 2016 - Dec 2017
    Inclusion and Exclusion 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.