Trial record 1 of 1 for:
20130287
Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia (BANTING)
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| ClinicalTrials.gov Identifier: NCT02739984 |
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Recruitment Status :
Completed
First Posted : April 15, 2016
Results First Posted : August 31, 2018
Last Update Posted : August 31, 2018
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypercholesterolemia Mixed Dyslipidemia Type 2 Diabetes | Biological: Evolocumab Drug: Placebo to Evolocumab | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 424 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | May 17, 2016 |
| Actual Primary Completion Date : | August 3, 2017 |
| Actual Study Completion Date : | August 3, 2017 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
Drug Information available for:
Evolocumab
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Participants received placebo subcutaneous injection once every month (QM) for 12 weeks.
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Drug: Placebo to Evolocumab
Administered by subcutaneous injection with an automated mini doser |
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Experimental: Evolocumab
Participants received 420 mg evolocumab subcutaneous injection once every month (QM) for 12 weeks.
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Biological: Evolocumab
Administered by subcutaneous injection with an automated mini doser
Other Names:
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Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- 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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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): NCT02739984
Locations
Show 66 study locations
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
Study Documents (Full-Text)
Documents provided by Amgen:
Documents provided by Amgen:
Study Protocol [PDF] January 6, 2016
Statistical Analysis Plan [PDF] December 22, 2016
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT02739984 |
| Other Study ID Numbers: |
20130287 2015-004711-21 ( EudraCT Number ) |
| First Posted: | April 15, 2016 Key Record Dates |
| Results First Posted: | August 31, 2018 |
| Last Update Posted: | August 31, 2018 |
| Last Verified: | August 2018 |
Keywords provided by Amgen:
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diabetes type 2 diabetes high blood cholesterol hypercholesterolemia |
mixed dyslipidemia high cholesterol statin intolerant |
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2 Hypercholesterolemia Dyslipidemias Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Hyperlipidemias Lipid Metabolism Disorders |
Evolocumab Antibodies, Monoclonal Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Immunologic Factors Physiological Effects of Drugs |