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Trial record 1 of 1 for:    20120119
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Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia (BERSON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02662569
Recruitment Status : Completed
First Posted : January 25, 2016
Results First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes, Hyperlipidemia, Mixed Dyslipidemia Biological: Evolocumab Drug: Atorvastatin Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 986 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : April 14, 2016
Actual Primary Completion Date : December 6, 2017
Actual Study Completion Date : December 6, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Atorvastatin (Q2W)
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.
Drug: Atorvastatin
Administered orally once a day
Other Name: Lipitor

Other: Placebo
Placebo to evolocumab administered by subcutaneous injection

Active Comparator: Atorvastatin (QM)
Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.
Drug: Atorvastatin
Administered orally once a day
Other Name: Lipitor

Other: Placebo
Placebo to evolocumab administered by subcutaneous injection

Experimental: Evolocumab Q2W + Atorvastatin
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • AMG 145
  • Repatha

Drug: Atorvastatin
Administered orally once a day
Other Name: Lipitor

Experimental: Evolocumab QM + Atorvastatin
Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • AMG 145
  • Repatha

Drug: Atorvastatin
Administered orally once a day
Other Name: Lipitor




Primary Outcome Measures :
  1. Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and weeks 10 and 12 ]
  2. Percent Change From Baseline in LDL-C at Week 12 [ Time Frame: Baseline and week 12 ]

Secondary Outcome Measures :
  1. Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and weeks 10 and 12 ]
  2. Change From Baseline in LDL-C at Week 12 [ Time Frame: Baseline and week 12 ]
  3. Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and weeks 10 and 12 ]
  4. Percent Change From Baseline in Non-HDL-C at Week 12 [ Time Frame: Baseline and week 12 ]
  5. Percent Change From Baseline in Apolipoprotein B100 at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and weeks 10 and 12 ]
  6. Percent Change From Baseline in Apolipoprotein B100 at Week 12 [ Time Frame: Baseline and week 12 ]
  7. Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and weeks 10 and 12 ]
  8. Percent Change From Baseline in Total Cholesterol at Week 12 [ Time Frame: Baseline and week 12 ]
  9. Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and weeks 10 and 12 ]
  10. Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 [ Time Frame: Baseline and week 12 ]
  11. Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and weeks 10 and 12 ]
  12. Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at Week 12 [ Time Frame: Baseline and week 12 ]
  13. Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L) [ Time Frame: Weeks 10 and 12 ]
  14. Percentage of Participants With LDL-C Less Than 70 mg/dL (1.8 mmol/L) at Week 12 [ Time Frame: Week 12 ]
  15. Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and weeks 10 and 12 ]
  16. Percent Change From Baseline in Lipoprotein(a) at Week 12 [ Time Frame: Baseline and week 12 ]
  17. Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and weeks 10 and 12 ]
  18. Percent Change From Baseline in Triglycerides at Week 12 [ Time Frame: Baseline and week 12 ]
  19. Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and weeks 10 and 12 ]
  20. Percent Change From Baseline in HDL-C at Week 12 [ Time Frame: Baseline and week 12 ]
  21. Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and weeks 10 and 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662569


Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
  Study Documents (Full-Text)

Documents provided by Amgen:
Study Protocol  [PDF] November 11, 2015
Statistical Analysis Plan  [PDF] July 14, 2017


Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02662569    
Other Study ID Numbers: 20120119
2013-000723-14 ( EudraCT Number )
First Posted: January 25, 2016    Key Record Dates
Results First Posted: January 11, 2019
Last Update Posted: January 11, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Dyslipidemias
Hyperlipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Evolocumab
Antibodies, Monoclonal
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Immunologic Factors
Physiological Effects of Drugs