drugset / Trial / NCT02739984
Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2016-05-17
- Primary completion
- 2017-08-03
- Completion
- 2017-08-03
Outcome
Met primary endpoint
paper Evolocumab decreased LDL-C by 54.3% (1.4%) at week 12 (vs 1.1% [1.9%] decrease with placebo; p < 0.0001) PMID 30953107 ↗
paper and by 65.0% (1.3%) at the mean of weeks 10 and 12 (vs 0.8% [1.8%] decrease with placebo; p < 0.0001) PMID 30953107 ↗
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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Evolocumab | Monoclonal antibody | 420 mg | Subcutaneous |