HypercholesterolemiaPhase 3BANTINGNCT02739984
Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia
A Phase 3 study testing Evolocumab in people with Hypercholesterolemia and Mixed Dyslipidemia, run by Amgen at 66 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia, Mixed Dyslipidemia, Type 2 Diabetes
- What is being tested?
- Evolocumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 424 participants
- Where
- 66 sitesin 7 countries
- Study dates
- 17 May 2016to 3 Aug 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
66 sites in 7 countries.
66 sites in 7 countries
United States46 sites
Research Site
Albuquerque, New Mexico, 87106
Research Site
Auburn, Maine, 04210
Research Site
Austin, Texas, 78749
Research Site
Bay City, Michigan, 48706
Research Site
Boca Raton, Florida, 33434
Research Site
Chicago, Illinois, 60611
Research Site
Chicago, Illinois, 60612
Research Site
Chicago, Illinois, 60616
Research Site
Columbus, Ohio, 43203
Research Site
Coral Gables, Florida, 33134
Research Site
Daytona Beach, Florida, 32117
Research Site
Denver, Colorado, 80246
Research Site
Dunwoody, Georgia, 30338
Research Site
Fleming Island, Florida, 32003
Research Site
Hollywood, Florida, 33021
Research Site
Houston, Texas, 77070
Research Site
Inverness, Florida, 34452
Research Site
Jacksonville, Florida, 32216
Research Site
Lakewood, Colorado, 80227
Research Site
Las Vegas, Nevada, 89148
Research Site
Lomita, California, 90717
Research Site
Los Angeles, California, 90057
Research Site
Louisville, Kentucky, 40213
Research Site
Meridian, Idaho, 83642
Research Site
Methuen, Massachusetts, 01844
Research Site
Miami, Florida, 33135
Research Site
Miami, Florida, 33136
Research Site
New Windsor, New York, 12553
Research Site
New York, New York, 10016
Research Site
New York, New York, 10029
Research Site
Norman, Oklahoma, 73069
Research Site
Phoenix, Arizona, 85012
Research Site
Roseville, California, 95661
Research Site
Salisbury, Maryland, 21804
Research Site
San Ramon, California, 94583
Research Site
Scarborough, Maine, 04074
Research Site
Shelby, North Carolina, 28150
Research Site
Spring Valley, California, 91978
Research Site
Suffolk, Virginia, 23435
Research Site
Tabor City, North Carolina, 28463
Research Site
Tarzana, California, 91356
Research Site
Tupelo, Mississippi, 38801
Research Site
Tuscumbia, Alabama, 35674
Research Site
Walnut Creek, California, 94598
Research Site
West Palm Beach, Florida, 33401
Research Site
Wilmington, Delaware, 19803
Canada4 sites
Research Site
Gatineau, Quebec, J8Y 6S8
Research Site
Montreal, Quebec, H1Y 3L1
Research Site
Saint-Jérôme, Quebec, J7Z 5T3
Research Site
Vancouver, British Columbia, V5Y 3W2
Poland4 sites
Research Site
Katowice, 40-040
Research Site
Krakow, 31-315
Research Site
Warsaw, 02-018
Research Site
Wroclaw, 50-306
Spain4 sites
Research Site
Almería, Andalusia, 04001
Research Site
Badalona, Catalonia, 08916
Research Site
Barcelona, Catalonia, 08036
Research Site
Granada, Andalusia, 18016
Belgium3 sites
Research Site
Edegem, 2650
Research Site
Leuven, 3000
Research Site
Liège, 4000
Italy3 sites
Research Site
Roma, 00128
Research Site
Roma, 00133
Research Site
Verona, 37126
Mexico2 sites
Research Site
Chihuahua City, 31217
Research Site
Guadalajara, Jalisco, 44600
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Evolocumab (AMG 145) on LDL-C in Subjects With Type 2 Diabetes Mellitus and Hypercholesterolemia/Mixed Dyslipidemia
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.
- Conditions
- Hypercholesterolemia, Mixed Dyslipidemia, Type 2 Diabetes
- Being tested
- Evolocumab, Placebo to Evolocumab
- Keywords
- diabetes, type 2 diabetes, high blood cholesterol, hypercholesterolemia, mixed dyslipidemia, high cholesterol, statin intolerant
- Medical subject headings
- Hypercholesterolemia, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolocumabBiological
Also called Repatha, AMG 145
Administered by subcutaneous injection with an automated mini doser
Placebo to EvolocumabDrug
Administered by subcutaneous injection with an automated mini doser
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received placebo subcutaneous injection once every month (QM) for 12 weeks. Receives: Drug: Placebo to Evolocumab |
| Evolocumab | Experimental | Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks. Receives: Biological: Evolocumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Measured: Baseline and Weeks 10 and 12
Percent Change From Baseline in LDL-C at Week 12
Measured: Baseline and week 12
Secondary outcomes (20)
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Change From Baseline in LDL-C at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in Non-HDL-C at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in Total Cholesterol at Week 12
Measured: Baseline and week 12
Percentage of Participants With Mean LDL-C at Weeks 10 and 12 Less Than 70 mg/dL (1.8 mmol/L)
Measured: Weeks 10 and 12
Percentage of Participants With LDL-C at Week 12 Less Than 70 mg/dL (1.8 mmol/L)
Measured: Week 12
Percentage of Participants With at Least a 50% Reduction From Baseline in Mean LDL-C at Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percentage of Participants With at Least a 50% Reduction From Baseline in LDL-C at Week 12
Measured: Baseline and Week 12
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in Lipoprotein(a) at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in Triglycerides at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in HDL-C at Week 12
Measured: Baseline and week 12
Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12
Measured: Baseline and weeks 10 and 12
Percent Change From Baseline in VLDL-C at Week 12
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study start17 May 2016
- Primary completion3 Aug 2017
- Study completion3 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739984
- Sponsor's protocol ID
- 20130287
- Other IDs
- 2015-004711-21, 2015
- Acronym
- BANTING
- Status last verified
- Aug 2018
- First submitted
- 12 Apr 2016
- Last updated
- 31 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 36435949Rosenson 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 at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Evolocumab (AMG 145) on LDL-C in Subjects With Type 2 Diabetes Mellitus and Hypercholesterolemia/Mixed Dyslipidemia
- ClinicalTrials.gov ID
- NCT02739984
- Acronym / sponsor ID
- BANTING / 20130287
- Conditions
- Hypercholesterolemia, Mixed Dyslipidemia, Type 2 Diabetes
- Keywords
- diabetes, type 2 diabetes, high blood cholesterol, hypercholesterolemia, mixed dyslipidemia, high cholesterol, statin intolerant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 17 May 2016 (actual)
- Primary completion
- 3 Aug 2017 (actual)
- Study completion
- 3 Aug 2017 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Posted 31 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo to EvolocumabParticipants received placebo subcutaneous injection once every month (QM) for 12 weeks. |
| Evolocumab | Experimental | Biological: EvolocumabParticipants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvolocumabAlso: Repatha, AMG 145Administered by subcutaneous injection with an automated mini doser | Biological | Evolocumab |
| Placebo to EvolocumabAdministered by subcutaneous injection with an automated mini doser | Drug | Placebo |
Primary outcome
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
20 secondary outcomes
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 B at the Mean of Weeks 10 and 12
Time frame: Baseline and weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B 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
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
Percentage of Participants With LDL-C at Week 12 Less Than 70 mg/dL (1.8 mmol/L)
Time frame: Week 12
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
Percentage of Participants With at Least a 50% Reduction From Baseline in LDL-C at Week 12
Time frame: Baseline and 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
Percent Change From Baseline in VLDL-C at Week 12
Time frame: Baseline and week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36435949Rosenson 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.
- Derived from this study: PubMed 30953107Rosenson 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.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
66 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Evolocumab in people with Hypercholesterolemia and Mixed Dyslipidemia, run by Amgen at 66 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, Canada, Poland, Spain, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 (time frame: Baseline and Weeks 10 and 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02739984, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.