Lead Investigator: Matthew Gilbert, University of Vermont
Title of Proposal Research: Effect of Albiglutide on Cardiovascular Outcomes in Older Adults with Type 2 Diabetes: A Post Hoc Analysis of a Randomized Controlled Trial
Vivli Data Request: 5435
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
The complications of type 2 diabetes increase with age, making treatment of older persons a challenge. Clinical studies on the effect of diabetes treatments on cardiovascular events in older adults are limited. Glucagon-like peptide 1 agonists are among the newer classes of diabetes medications to treat type 2 diabetes. Some of the agents in this class of mediation have been shown to reduce the risk of cardiovascular death in patients with type 2 diabetes who already have cardiovascular disease. The purpose of our study is to see if this beneficial effect of this medication is seen in older adults with type 2 diabetes treated with albiglutide. A secondary analysis of data from the LEADER clinical trial evaluated whether age interacted with liraglutide for major cardiovascular outcomes (1). Although the age-treatment interaction was not statistically significant, a trend for greater efficacy was seen in the 75+ age group. We would like to replicate the same analyses using data from the NCT02465515 trial of diabetics aged >75 years and aged >65 to <75 years with established cardiovascular disease.
Statistical Analysis Plan:
Our plan is to investigate the effect of albiglutide compared with placebo on the primary and secondary outcomes for patients >75 years and aged >65 to <75 years with cardiovascular disease. The time to event analysis of the primary cardiovascular outcome will be assessed in the intention to treat population by use of Cox proportional hazards regression. The Kaplan-Meier will be used to estimate event rates. The primary composite outcome will be analyzed by specified subgroups that were defined by baseline characteristics, including age at randomization. The Cox regression analyses will include available covariates known to be associated with the outcomes, including sex, BMI, CV history, smoking status, blood pressure, eGFR, duration of diabetes, and baseline medications. The analyses of the Albiglutide study data would be run using SAS on your premium research platform.
Requested Studies:
A Long Term, Randomised, Double Blind, Placebo-controlled Study to Determine the Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Patients With Type 2 Diabetes Mellitus
Sponsor: GlaxoSmithKline
Study ID: NCT02465515
Sponsor ID: GLP116174
Public Disclosures:
Gilbert, M.P., Skelly, J., Hernandez, A.F., Green, J.B., Krychtiuk, K.A., Granger, C.B., Leiter, L.A., McMurray, J.J., Del Prato, S. and Pratley, R.E., 2024. Effect of albiglutide on cardiovascular outcomes in older adults: A post hoc analysis of a randomized controlled trial. Diabetes, Obesity and Metabolism. Doi : 10.1111/dom.15479