Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia (BERSON)
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ClinicalTrials.gov Identifier: NCT02662569 |
Recruitment Status :
Completed
First Posted : January 25, 2016
Results First Posted : January 11, 2019
Last Update Posted : January 11, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes, Hyperlipidemia, Mixed Dyslipidemia | Biological: Evolocumab Drug: Atorvastatin Other: Placebo | Phase 3 |
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 |

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:
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:
Drug: Atorvastatin Administered orally once a day
Other Name: Lipitor |
- Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and weeks 10 and 12 ]
- Percent Change From Baseline in LDL-C at Week 12 [ Time Frame: Baseline and week 12 ]
- Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and weeks 10 and 12 ]
- Change From Baseline in LDL-C at Week 12 [ Time Frame: Baseline and week 12 ]
- Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and weeks 10 and 12 ]
- Percent Change From Baseline in Non-HDL-C at Week 12 [ Time Frame: Baseline and week 12 ]
- Percent Change From Baseline in Apolipoprotein B100 at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and weeks 10 and 12 ]
- Percent Change From Baseline in Apolipoprotein B100 at Week 12 [ Time Frame: Baseline and week 12 ]
- Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and weeks 10 and 12 ]
- Percent Change From Baseline in Total Cholesterol at Week 12 [ Time Frame: Baseline and week 12 ]
- 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 ]
- Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 [ Time Frame: Baseline and week 12 ]
- 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 ]
- Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at Week 12 [ Time Frame: Baseline and week 12 ]
- 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 ]
- Percentage of Participants With LDL-C Less Than 70 mg/dL (1.8 mmol/L) at Week 12 [ Time Frame: Week 12 ]
- Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and weeks 10 and 12 ]
- Percent Change From Baseline in Lipoprotein(a) at Week 12 [ Time Frame: Baseline and week 12 ]
- Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and weeks 10 and 12 ]
- Percent Change From Baseline in Triglycerides at Week 12 [ Time Frame: Baseline and week 12 ]
- Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and weeks 10 and 12 ]
- Percent Change From Baseline in HDL-C at Week 12 [ Time Frame: Baseline and week 12 ]
- Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12 [ Time Frame: Baseline and weeks 10 and 12 ]

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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 |
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.

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

Study Director: | MD | Amgen |
Documents provided by Amgen:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Dyslipidemias Hyperlipidemias Hyperlipoproteinemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Evolocumab |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |