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CompletedNCT02739984BANTINGUpdated Aug 31, 2018Results posted

Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia

A Phase 3 interventional study of Evolocumab and Placebo to Evolocumab in Hypercholesterolemia, Mixed Dyslipidemia and Type 2 Diabetes, sponsored by Amgen. Completed at 66 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-31.

Sponsored by Amgen · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
424
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein cholesterol (LDL-C) in adults with type 2 diabetes mellitus and high blood cholesterol on a maximally tolerated oral dose of statin of at least moderate-intensity.

Read the detailed description

This study will enroll adults with type 2 diabetes mellitus and elevated LDL-C or non-high-density lipoprotein cholesterol (non-HDL-C) levels on a stable, maximally tolerated statin dose of at least moderate-intensity at signing of the informed consent; statin therapy must remain unchanged during screening and the remainder of the study.

02

Conditions studied

  • Hypercholesterolemia
  • Mixed Dyslipidemia
  • Type 2 Diabetes

Keywords

  • diabetes
  • type 2 diabetes
  • high blood cholesterol
  • hypercholesterolemia
  • mixed dyslipidemia
  • high cholesterol
  • statin intolerant
03

In context

Hypercholesterolemia

1,267 studies on the registry are indexed under Hypercholesterolemia; 105 are open to participants now.

This study's enrollment of 424 is above the median of 100 across 1,015 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Amgen is the lead sponsor of 1,044 studies on the registry; 51 are open to participants now.

Of its 246 completed or terminated interventional studies of FDA-regulated products, 164 (67%) have results posted.

Browse Amgen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female ≥ 18 years
  • Type 2 Diabetes Mellitus
  • Hemoglobin A1c \< 10%
  • Stable diabetes therapy
  • Must be on maximally tolerated dose of statin of at least moderate Intensity
  • Fasting triglycerides ≤ 600 mg/dL
  • Not at LDL-C or Non-HDL-C goal.

Exclusion criteria

Exclusion Criteria:

  • Moderate to severe renal dysfunction
  • Uncontrolled hypertension
  • Persistent active liver disease or hepatic dysfunction
  • Has taken a cholesterylester transfer protein inhibitor in the last 12 months,
  • Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft or stroke within 3 months prior to randomization
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
424 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.

    Drug: Placebo to Evolocumab

  • Experimental
    Evolocumab

    Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.

    Biological: Evolocumab

Interventions

  • BiologicalEvolocumab

    Administered by subcutaneous injection with an automated mini doser

    Also known as: Repatha, AMG 145

  • DrugPlacebo to Evolocumab

    Administered by subcutaneous injection with an automated mini doser

06

What researchers measure

Primary outcomes

  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 outcomes

  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 B at the Mean of Weeks 10 and 12

    Time frame: Baseline and weeks 10 and 12

  6. Percent Change From Baseline in Apolipoprotein B 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. Percentage of Participants With Mean LDL-C at Weeks 10 and 12 Less Than 70 mg/dL (1.8 mmol/L)

    Time frame: Weeks 10 and 12

  10. Percentage of Participants With LDL-C at Week 12 Less Than 70 mg/dL (1.8 mmol/L)

    Time frame: Week 12

  11. Percentage of Participants With at Least a 50% Reduction From Baseline in Mean LDL-C at Weeks 10 and 12

    Time frame: Baseline and weeks 10 and 12

  12. Percentage of Participants With at Least a 50% Reduction From Baseline in LDL-C at Week 12

    Time frame: Baseline and Week 12

  13. Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12

    Time frame: Baseline and weeks 10 and 12

  14. Percent Change From Baseline in Lipoprotein(a) at Week 12

    Time frame: Baseline and week 12

  15. Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12

    Time frame: Baseline and weeks 10 and 12

  16. Percent Change From Baseline in Triglycerides at Week 12

    Time frame: Baseline and week 12

  17. Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12

    Time frame: Baseline and weeks 10 and 12

  18. Percent Change From Baseline in HDL-C at Week 12

    Time frame: Baseline and week 12

  19. Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12

    Time frame: Baseline and weeks 10 and 12

  20. Percent Change From Baseline in VLDL-C at Week 12

    Time frame: Baseline and week 12

07

Results

Posted Aug 31, 2018

Participant flow

Of 853 patients screened, a total of 424 participants were randomized at 58 centers in Belgium, Canada, Italy, Mexico, Poland, Spain and the United States from 17 May 2016 to 05 May 2017.

Participant flow — Overall Study
MilestonePlaceboEvolocumab
Started143281
Received study drug141280
Completed138279
Not completed52
Withdrew: Sponsor decision10
Withdrew: Withdrawal by subject11
Withdrew: Death01
Withdrew: Lost to follow-up30

Outcome measures

PrimaryPercent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time frame:
Baseline and Weeks 10 and 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
percent changePlaceboEvolocumab
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12-0.84 ± 1.76-64.98 ± 1.31
Statistical analysis
  • Placebo vs Evolocumab · Repeated measures linear effects model · p = <0.0001 · Ls mean treatment difference: -64.14 · 95% CI -68.16 to -60.12Evolocumab - Placebo
PrimaryPercent Change From Baseline in LDL-C at Week 12
Time frame:
Baseline and week 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in LDL-C at Week 12
percent changePlaceboEvolocumab
Percent Change From Baseline in LDL-C at Week 12-1.14 ± 1.92-54.28 ± 1.42
Statistical analysis
  • Placebo vs Evolocumab · Repeated measures linear effects model · p = <0.0001 · Ls mean treatment difference: -53.14 · 95% CI -57.56 to -48.71Evolocumab - Placebo
SecondaryChange From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time frame:
Baseline and weeks 10 and 12
Reported as:
Least squares mean · mg/dL
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
mg/dLPlaceboEvolocumab
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12-8.3 ± 2.2-75.5 ± 1.6
Statistical analysis
  • Placebo vs Evolocumab · Repeated measures linear effects model · p = <0.0001 · Ls mean treatment difference: -67.2 · 95% CI -72.1 to -62.2Evolocumab - Placebo
SecondaryChange From Baseline in LDL-C at Week 12
Time frame:
Baseline and week 12
Reported as:
Least squares mean · mg/dL
Change From Baseline in LDL-C at Week 12
mg/dLPlaceboEvolocumab
Change From Baseline in LDL-C at Week 12-8.6 ± 2.3-64.4 ± 1.7
Statistical analysis
  • Placebo vs Evolocumab · Repeated measures linear effects model · p = <0.0001 · Ls mean treatment difference: -55.8 · 95% CI -61.0 to -50.5Evolocumab - Placebo
SecondaryPercent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
Time frame:
Baseline and weeks 10 and 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
percent changePlaceboEvolocumab
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12-0.05 ± 1.63-56.62 ± 1.21
Statistical analysis
  • Placebo vs Evolocumab · Repeated measures linear effects model · p = <0.0001 · Ls mean treatment difference: -56.56 · 95% CI -60.28 to -52.85Evolocumab - Placebo
SecondaryPercent Change From Baseline in Non-HDL-C at Week 12
Time frame:
Baseline and week 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Non-HDL-C at Week 12
percent changePlaceboEvolocumab
Percent Change From Baseline in Non-HDL-C at Week 12-0.60 ± 1.79-46.89 ± 1.33
Statistical analysis
  • Placebo vs Evolocumab · Repeated measures linear effects model · p = <0.0001 · Ls mean treatment difference: -46.28 · 95% CI -50.42 to -42.15Evolocumab - Placebo
SecondaryPercent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Time frame:
Baseline and weeks 10 and 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
percent changePlaceboEvolocumab
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 122.31 ± 1.58-50.17 ± 1.18
Statistical analysis
  • Placebo vs Evolocumab · Repeated measures linear effects model · p = <0.0001 · Ls mean treatment difference: -52.48 · 95% CI -56.10 to -48.85Evolocumab - Placebo
SecondaryPercent Change From Baseline in Apolipoprotein B at Week 12
Time frame:
Baseline and week 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Apolipoprotein B at Week 12
percent changePlaceboEvolocumab
Percent Change From Baseline in Apolipoprotein B at Week 121.78 ± 1.73-40.34 ± 1.29
Statistical analysis
  • Placebo vs Evolocumab · Repeated measures linear effects model · p = <0.0001 · Ls mean treatment difference: -42.12 · 95% CI -46.13 to -38.11Evolocumab - Placebo
SecondaryPercent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12
Time frame:
Baseline and weeks 10 and 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12
percent changePlaceboEvolocumab
Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12-1.13 ± 1.24-42.19 ± 0.92
Statistical analysis
  • Placebo vs Evolocumab · Repeated measures linear effects model · p = <0.0001 · Ls mean treatment difference: -41.06 · 95% CI -43.90 to -38.22Evolocumab - Placebo
SecondaryPercent Change From Baseline in Total Cholesterol at Week 12
Time frame:
Baseline and week 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Total Cholesterol at Week 12
percent changePlaceboEvolocumab
Percent Change From Baseline in Total Cholesterol at Week 12-1.23 ± 1.36-34.97 ± 1.01
Statistical analysis
  • Placebo vs Evolocumab · Repeated measures linear effects model · p = <0.0001 · Ls mean treatment difference: -33.74 · 95% CI -36.87 to -30.60Evolocumab - Placebo
SecondaryPercentage of Participants With Mean LDL-C at Weeks 10 and 12 Less Than 70 mg/dL (1.8 mmol/L)
Time frame:
Weeks 10 and 12
Reported as:
Number · percentage of participants
Percentage of Participants With Mean LDL-C at Weeks 10 and 12 Less Than 70 mg/dL (1.8 mmol/L)
percentage of participantsPlaceboEvolocumab
Percentage of Participants With Mean LDL-C at Weeks 10 and 12 Less Than 70 mg/dL (1.8 mmol/L)14.8 (9.8 to 21.8)92.7 (89.0 to 95.2)
Statistical analysis
  • Placebo vs Evolocumab · Cochran-Mantel-Haenszel · p = <0.0001 · Treatment difference: 77.9 · 95% CI 70.0 to 83.5Evolocumab - Placebo
SecondaryPercentage of Participants With LDL-C at Week 12 Less Than 70 mg/dL (1.8 mmol/L)
Time frame:
Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With LDL-C at Week 12 Less Than 70 mg/dL (1.8 mmol/L)
percentage of participantsPlaceboEvolocumab
Percentage of Participants With LDL-C at Week 12 Less Than 70 mg/dL (1.8 mmol/L)15.4 (10.2 to 22.6)84.5 (79.5 to 88.5)
Statistical analysis
  • Placebo vs Evolocumab · Cochran-Mantel-Haenszel · p = <0.0001 · Treatment difference: 69.1 · 95% CI 60.4 to 75.7Evolocumab - Placebo
SecondaryPercentage of Participants With at Least a 50% Reduction From Baseline in Mean LDL-C at Weeks 10 and 12
Time frame:
Baseline and weeks 10 and 12
Reported as:
Number · percentage of participants
Percentage of Participants With at Least a 50% Reduction From Baseline in Mean LDL-C at Weeks 10 and 12
percentage of participantsPlaceboEvolocumab
Percentage of Participants With at Least a 50% Reduction From Baseline in Mean LDL-C at Weeks 10 and 120.7 (0.1 to 4.1)84.2 (79.5 to 88.1)
Statistical analysis
  • Placebo vs Evolocumab · Cochran-Mantel-Haenszel · p = <0.0001 · Treatment difference: 83.5 · 95% CI 77.7 to 87.4Evolocumab - Placebo
SecondaryPercentage of Participants With at Least a 50% Reduction From Baseline in LDL-C at Week 12
Time frame:
Baseline and Week 12
Reported as:
Number · percentage of participants
Percentage of Participants With at Least a 50% Reduction From Baseline in LDL-C at Week 12
percentage of participantsPlaceboEvolocumab
Percentage of Participants With at Least a 50% Reduction From Baseline in LDL-C at Week 120.8 (0.1 to 4.2)65.5 (59.4 to 71.1)
Statistical analysis
  • Placebo vs Evolocumab · Cochran-Mantel-Haenszel · p = <0.0001 · Treatment difference: 64.7 · 95% CI 57.7 to 70.3Evolocumab - Placebo
SecondaryPercent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
Time frame:
Baseline and weeks 10 and 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
percent changePlaceboEvolocumab
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 129.63 ± 3.29-30.87 ± 2.43
Statistical analysis
  • Placebo vs Evolocumab · Repeated measures linear effects model · p = <0.0001 · Ls mean treatment difference: -40.50 · 95% CI -48.11 to -32.90Evolocumab - Placebo
SecondaryPercent Change From Baseline in Lipoprotein(a) at Week 12
Time frame:
Baseline and week 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Lipoprotein(a) at Week 12
percent changePlaceboEvolocumab
Percent Change From Baseline in Lipoprotein(a) at Week 127.38 ± 3.06-25.18 ± 2.28
Statistical analysis
  • Placebo vs Evolocumab · Repeated measures linear effects model · p = <0.0001 · Ls mean treatment difference: -32.56 · 95% CI -39.58 to -25.53Evolocumab - Placebo
SecondaryPercent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Time frame:
Baseline and weeks 10 and 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
percent changePlaceboEvolocumab
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 126.61 ± 2.94-12.64 ± 2.19
Statistical analysis
  • Placebo vs Evolocumab · Repeated measures linear effects model · p = <0.0001 · Ls mean treatment difference: -19.25 · 95% CI -25.95 to -12.54Evolocumab - Placebo
SecondaryPercent Change From Baseline in Triglycerides at Week 12
Time frame:
Baseline and week 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Triglycerides at Week 12
percent changePlaceboEvolocumab
Percent Change From Baseline in Triglycerides at Week 124.81 ± 3.41-8.90 ± 2.52
Statistical analysis
  • Placebo vs Evolocumab · Repeated measures linear effects model · p = <0.0001 · Ls mean treatment difference: -13.70 · 95% CI -21.60 to -5.80Evolocumab - Placebo
SecondaryPercent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
Time frame:
Baseline and weeks 10 and 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
percent changePlaceboEvolocumab
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12-2.57 ± 1.257.23 ± 0.93
Statistical analysis
  • Placebo vs Evolocumab · Repeated measures linear effects model · p = <0.0001 · Ls mean treatment difference: 9.80 · 95% CI 6.95 to 12.64Evolocumab - Placebo
SecondaryPercent Change From Baseline in HDL-C at Week 12
Time frame:
Baseline and week 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in HDL-C at Week 12
percent changePlaceboEvolocumab
Percent Change From Baseline in HDL-C at Week 12-1.41 ± 1.385.96 ± 1.02
Statistical analysis
  • Placebo vs Evolocumab · Repeated measures linear effects model · p = <0.0001 · Ls mean treatment difference: 7.37 · 95% CI 4.19 to 10.56Evolocumab - Placebo
SecondaryPercent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12
Time frame:
Baseline and weeks 10 and 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12
percent changePlaceboEvolocumab
Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 123.42 ± 2.57-13.64 ± 1.89
Statistical analysis
  • Placebo vs Evolocumab · Repeated measures linear effects model · p = <0.0001 · Ls mean treatment difference: -17.06 · 95% CI -22.91 to -11.21Evolocumab - Placebo
SecondaryPercent Change From Baseline in VLDL-C at Week 12
Time frame:
Baseline and week 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in VLDL-C at Week 12
percent changePlaceboEvolocumab
Percent Change From Baseline in VLDL-C at Week 123.02 ± 2.94-10.31 ± 2.15
Statistical analysis
  • Placebo vs Evolocumab · Repeated measures linear effects model · p = <0.0001 · Ls mean treatment difference: -13.33 · 95% CI -20.09 to -6.56Evolocumab - Placebo

Adverse events

Collected over From the first dose of study drug (placebo or evolocumab) to week 12.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/141 (0%)2/141 (1.4%)19/141 (13.5%)
Evolocumab1/280 (0.4%)14/280 (5%)37/280 (13.2%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventPlaceboEvolocumab
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders0/1414/280
Coronary artery diseaseCardiac disorders0/1412/280
Peptic ulcerGastrointestinal disorders1/1410/280
Osteomyelitis chronicInfections and infestations1/1410/280
Atrial fibrillationCardiac disorders0/1411/280
Sudden cardiac deathGeneral disorders0/1411/280
CellulitisInfections and infestations0/1411/280
Gastroenteritis viralInfections and infestations0/1411/280
PneumoniaInfections and infestations0/1411/280
Pneumonia bacterialInfections and infestations0/1411/280
Most frequent other events
Most frequent other events
EventPlaceboEvolocumab
HypertensionVascular disorders0/14111/280
Diabetes mellitusMetabolism and nutrition disorders5/1418/280
DiarrhoeaGastrointestinal disorders4/1416/280
Viral upper respiratory tract infectionInfections and infestations4/1415/280
Urinary tract infectionInfections and infestations2/1416/280
HeadacheNervous system disorders3/1416/280
PharyngitisInfections and infestations3/1410/280
Back painMusculoskeletal and connective tissue disorders3/1412/280

Baseline characteristics

All randomized participants

Age, Continuous
Age, Continuous(years)PlaceboEvolocumabTotal
Mean62.3 ± 8.562.5 ± 8.562.5 ± 8.5
Age, Customized
Age, Customized(Participants)PlaceboEvolocumabTotal
< 65 years86159245
65 - < 85 years57122179
≥ 85 years000
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboEvolocumabTotal
Female65121186
Male78160238
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboEvolocumabTotal
Hispanic or Latino245478
Not Hispanic or Latino119227346
Unknown or Not Reported000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboEvolocumabTotal
American Indian or Alaska Native7815
Asian246
Black (or African American)324173
Native Hawaiian or Other Pacific Islander022
White102223325
Multiple011
Other022
Stratification Factor: Low-density Lipoprotein Cholesterol (LDL-C) Level
Stratification Factor: Low-density Lipoprotein Cholesterol (LDL-C) Level(Participants)PlaceboEvolocumabTotal
< 130 mg/dL108213321
≥ 130 mg/dL3568103
LDL-C Concentration
LDL-C Concentration(mg/dL)PlaceboEvolocumabTotal
Mean110.4 ± 33.0108.6 ± 31.0109.2 ± 31.6
Non-High-density Lipoprotein Cholesterol (non-HDL-C) Concentration
Non-High-density Lipoprotein Cholesterol (non-HDL-C) Concentration(mg/dL)PlaceboEvolocumabTotal
Mean145.5 ± 33.9144.6 ± 34.9144.9 ± 34.5

6 further baseline measures are reported on the registry.

08

Study locations

66 sites
  • Research Site
    Tuscumbia, Alabama 35674, United States
  • Research Site
    Phoenix, Arizona 85012, United States
  • Research Site
    Lomita, California 90717, United States
  • Research Site
    Los Angeles, California 90057, United States
  • Research Site
    Roseville, California 95661, United States
  • Research Site
    San Ramon, California 94583, United States
  • Research Site
    Spring Valley, California 91978, United States
  • Research Site
    Tarzana, California 91356, United States
  • Research Site
    Walnut Creek, California 94598, United States
  • Research Site
    Denver, Colorado 80246, United States
  • Research Site
    Lakewood, Colorado 80227, United States
  • Research Site
    Wilmington, Delaware 19803, United States
  • Research Site
    Boca Raton, Florida 33434, United States
  • Research Site
    Coral Gables, Florida 33134, United States
  • Research Site
    Daytona Beach, Florida 32117, United States
  • Research Site
    Fleming Island, Florida 32003, United States
  • Research Site
    Hollywood, Florida 33021, United States
  • Research Site
    Inverness, Florida 34452, United States
  • Research Site
    Jacksonville, Florida 32216, United States
  • Research Site
    Miami, Florida 33135, United States
  • Research Site
    Miami, Florida 33136, United States
  • Research Site
    West Palm Beach, Florida 33401, United States
  • Research Site
    Dunwoody, Georgia 30338, United States
  • Research Site
    Meridian, Idaho 83642, United States
  • Research Site
    Chicago, Illinois 60611, United States
  • Research Site
    Chicago, Illinois 60612, United States
  • Research Site
    Chicago, Illinois 60616, United States
  • Research Site
    Louisville, Kentucky 40213, United States
  • Research Site
    Auburn, Maine 04210, United States
  • Research Site
    Scarborough, Maine 04074, United States
  • Research Site
    Salisbury, Maryland 21804, United States
  • Research Site
    Methuen, Massachusetts 01844, United States
  • Research Site
    Bay City, Michigan 48706, United States
  • Research Site
    Tupelo, Mississippi 38801, United States
  • Research Site
    Las Vegas, Nevada 89148, United States
  • Research Site
    Albuquerque, New Mexico 87106, United States
  • Research Site
    New Windsor, New York 12553, United States
  • Research Site
    New York, New York 10016, United States
  • Research Site
    New York, New York 10029, United States
  • Research Site
    Shelby, North Carolina 28150, United States
  • Research Site
    Tabor City, North Carolina 28463, United States
  • Research Site
    Columbus, Ohio 43203, United States
  • Research Site
    Norman, Oklahoma 73069, United States
  • Research Site
    Austin, Texas 78749, United States
  • Research Site
    Houston, Texas 77070, United States
  • Research Site
    Suffolk, Virginia 23435, United States
  • Research Site
    Edegem, 2650, Belgium
  • Research Site
    Leuven, 3000, Belgium
  • Research Site
    Liège, 4000, Belgium
  • Research Site
    Vancouver, British Columbia V5Y 3W2, Canada
  • Research Site
    Gatineau, Quebec J8Y 6S8, Canada
  • Research Site
    Montreal, Quebec H1Y 3L1, Canada
  • Research Site
    Saint-Jérôme, Quebec J7Z 5T3, Canada
  • Research Site
    Roma, 00128, Italy
  • Research Site
    Roma, 00133, Italy
  • Research Site
    Verona, 37126, Italy
  • Research Site
    Guadalajara, Jalisco 44600, Mexico
  • Research Site
    Chihuahua City, 31217, Mexico
  • Research Site
    Katowice, 40-040, Poland
  • Research Site
    Krakow, 31-315, Poland
  • Research Site
    Warsaw, 02-018, Poland
  • Research Site
    Wroclaw, 50-306, Poland
  • Research Site
    Almería, Andalusia 04001, Spain
  • Research Site
    Granada, Andalusia 18016, Spain
  • Research Site
    Badalona, Catalonia 08916, Spain
  • Research Site
    Barcelona, Catalonia 08036, Spain
09

References and documents

Publications

  • Rosenson RS, Lopez JAG, Monsalvo ML, Wu Y, Wang H, Marcovina SM. Quantification of LDL-Cholesterol Corrected for Molar Concentration of Lipoprotein(a). Cardiovasc Drugs Ther. 2024 Feb;38(1):191-197. doi: 10.1007/s10557-022-07407-y. Epub 2022 Nov 26. PubMed 36435949 ↗
  • Rosenson RS, Daviglus ML, Handelsman Y, Pozzilli P, Bays H, Monsalvo ML, Elliott-Davey M, Somaratne R, Reaven P. Efficacy and safety of evolocumab in individuals with type 2 diabetes mellitus: primary results of the randomised controlled BANTING study. Diabetologia. 2019 Jun;62(6):948-958. doi: 10.1007/s00125-019-4856-7. Epub 2019 Apr 5. PubMed 30953107 ↗

Study documents

  • Study protocol · Jan 6, 2016
  • Statistical analysis plan · Dec 22, 2016

Documents are hosted by the registry — open the source record to download them.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2016 to primary completion in Aug 2017, 14 months.

Results were first posted in Aug 2018, 1 year after primary completion.

Of 128 industry-sponsored phase 3 interventional studies under Hypercholesterolemia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 24. This study's 14 months is below that.

Counting every sponsor, half of 137 studies reached it within 18 months; a quarter within 12 and three quarters within 25.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 12, 2016
First posted
Apr 15, 2016
StartActual
May 17, 2016
Primary completionActual
Aug 3, 2017
CompletionActual
Aug 3, 2017
Results first posted
Aug 31, 2018
Last update
Aug 31, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02739984
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
Apr 15, 2016
Start date
May 17, 2016
Primary completion
Aug 3, 2017
Completion
Aug 3, 2017
Results posted
Aug 31, 2018
Last update
Aug 31, 2018

Study contacts

MD
study director · Amgen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Evolocumab

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