Regulatory decision criteria on the suitability of the glycated hemoglobin level (HbA1c) as a surrogate for cardiac events.

Proposal
11801

Title of Proposed Research

Lead Researcher

Malwina Mackowiak

Affiliation

Hochschule Koblenz - RheinAhrCampus Fachbereich Mathematik und Technik

Funding Source

Potential Conflicts of Interest

Data Sharing Agreement Date

27 September 2021

Lay Summary

A well observed fact is the higher incidence of cardiac events in patients suffering from diabetes. In the planned analysis, the suitability of the glycated hemoglobin level (HbA1c), which is a measure for the long-term glucose level, will be used to answer the question of whether HbA1c values can be taken as a predictor for the probability of experiencing a cardiac event. In this context, the following questions will be addressed:- how much does the probability of experiencing a cardiac event rise with an increase in the HbA1c value of 10% (and how crucial is the initial value)?- of what magnitude must the in- or decrease in the HbA1c be to show a significant change in the rate of cardiac events?

Study Data Provided

[{ "PostingID": 4730, "Title": "SANOFI-EFC11319", "Description": "A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate Cardiovascular Outcomes During Treatment With Lixisenatide in Type 2 Diabetic Patients After an Acute Coronary Syndrome / ELIXA" }]

Statistical Analysis Plan

Publication Citation