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

Primary Purpose

Hypercholesterolemia, Mixed Dyslipidemia, Type 2 Diabetes

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Evolocumab
Placebo to Evolocumab
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring diabetes, type 2 diabetes, high blood cholesterol, hypercholesterolemia, mixed dyslipidemia, high cholesterol, statin intolerant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Evolocumab

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Percent Change From Baseline in LDL-C at Week 12

Secondary Outcome Measures

Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Change From Baseline in LDL-C at Week 12
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
Percent Change From Baseline in Non-HDL-C at Week 12
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B at Week 12
Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12
Percent Change From Baseline in Total Cholesterol at Week 12
Percentage of Participants With Mean LDL-C at Weeks 10 and 12 Less Than 70 mg/dL (1.8 mmol/L)
Percentage of Participants With LDL-C at Week 12 Less Than 70 mg/dL (1.8 mmol/L)
Percentage of Participants With at Least a 50% Reduction From Baseline in Mean LDL-C at Weeks 10 and 12
Percentage of Participants With at Least a 50% Reduction From Baseline in LDL-C at Week 12
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
Percent Change From Baseline in Lipoprotein(a) at Week 12
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Percent Change From Baseline in Triglycerides at Week 12
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
Percent Change From Baseline in HDL-C at Week 12
Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12
Percent Change From Baseline in VLDL-C at Week 12

Full Information

First Posted
April 12, 2016
Last Updated
August 2, 2018
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT02739984
Brief Title
Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia
Acronym
BANTING
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 17, 2016 (Actual)
Primary Completion Date
August 3, 2017 (Actual)
Study Completion Date
August 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Mixed Dyslipidemia, Type 2 Diabetes
Keywords
diabetes, type 2 diabetes, high blood cholesterol, hypercholesterolemia, mixed dyslipidemia, high cholesterol, statin intolerant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
424 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
Arm Title
Evolocumab
Arm Type
Experimental
Arm Description
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
Intervention Type
Biological
Intervention Name(s)
Evolocumab
Other Intervention Name(s)
Repatha, AMG 145
Intervention Description
Administered by subcutaneous injection with an automated mini doser
Intervention Type
Drug
Intervention Name(s)
Placebo to Evolocumab
Intervention Description
Administered by subcutaneous injection with an automated mini doser
Primary Outcome Measure Information:
Title
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time Frame
Baseline and Weeks 10 and 12
Title
Percent Change From Baseline in LDL-C at Week 12
Time Frame
Baseline and week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time Frame
Baseline and weeks 10 and 12
Title
Change From Baseline in LDL-C at Week 12
Time Frame
Baseline and week 12
Title
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
Time Frame
Baseline and weeks 10 and 12
Title
Percent Change From Baseline in Non-HDL-C at Week 12
Time Frame
Baseline and week 12
Title
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Time Frame
Baseline and weeks 10 and 12
Title
Percent Change From Baseline in Apolipoprotein B at Week 12
Time Frame
Baseline and week 12
Title
Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12
Time Frame
Baseline and weeks 10 and 12
Title
Percent Change From Baseline in Total Cholesterol at Week 12
Time Frame
Baseline and week 12
Title
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
Title
Percentage of Participants With LDL-C at Week 12 Less Than 70 mg/dL (1.8 mmol/L)
Time Frame
Week 12
Title
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
Title
Percentage of Participants With at Least a 50% Reduction From Baseline in LDL-C at Week 12
Time Frame
Baseline and Week 12
Title
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
Time Frame
Baseline and weeks 10 and 12
Title
Percent Change From Baseline in Lipoprotein(a) at Week 12
Time Frame
Baseline and week 12
Title
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Time Frame
Baseline and weeks 10 and 12
Title
Percent Change From Baseline in Triglycerides at Week 12
Time Frame
Baseline and week 12
Title
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
Time Frame
Baseline and weeks 10 and 12
Title
Percent Change From Baseline in HDL-C at Week 12
Time Frame
Baseline and week 12
Title
Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12
Time Frame
Baseline and weeks 10 and 12
Title
Percent Change From Baseline in VLDL-C at Week 12
Time Frame
Baseline and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Tuscumbia
State/Province
Alabama
ZIP/Postal Code
35674
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Research Site
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Research Site
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Research Site
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
Research Site
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Research Site
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Research Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
Research Site
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80227
Country
United States
Facility Name
Research Site
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Research Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Facility Name
Research Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Research Site
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Research Site
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
Facility Name
Research Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Research Site
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Research Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Research Site
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Research Site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Research Site
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Research Site
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Research Site
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21804
Country
United States
Facility Name
Research Site
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Research Site
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Research Site
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Research Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Research Site
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Research Site
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Research Site
City
Tabor City
State/Province
North Carolina
ZIP/Postal Code
28463
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Facility Name
Research Site
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78749
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
Research Site
City
Suffolk
State/Province
Virginia
ZIP/Postal Code
23435
Country
United States
Facility Name
Research Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Y 3W2
Country
Canada
Facility Name
Research Site
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8Y 6S8
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1Y 3L1
Country
Canada
Facility Name
Research Site
City
St-Jérôme
State/Province
Quebec
ZIP/Postal Code
J7Z 5T3
Country
Canada
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Research Site
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Research Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Research Site
City
Chihuahua
ZIP/Postal Code
31217
Country
Mexico
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-315
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-018
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
50-306
Country
Poland
Facility Name
Research Site
City
Almeria
State/Province
Andalucía
ZIP/Postal Code
04001
Country
Spain
Facility Name
Research Site
City
Granada
State/Province
Andalucía
ZIP/Postal Code
18016
Country
Spain
Facility Name
Research Site
City
Badalona
State/Province
Cataluña
ZIP/Postal Code
08916
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
30953107
Citation
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.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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