Developing, Planning and Conducting an Interim Analysis: Lessons From the DEVOTE Cardiovascular Outcomes Trial (Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events)

What Was Tested

This randomized controlled trial paper looks at Insulin Glargine.

The FDA agreed that an interim analysis could form the basis for an early regulatory approval.

The researchers report here the operational model developed to support the DEVOTE interim analysis and the results.

Who Took Part

The Data Access Management Plan comprehensively described the interim analysis operational processes and procedures to maintain the integrity of the ongoing trial while the interim analysis was conducted, submitted, and acted upon by the FDA, and also until completion of the full trial.

How the Study Was Run

In design terms this was a randomized and double-blind study.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

Most importantly, those who were unblinded to the interim results were limited to a team of 14 members.

What Was Measured

The subject headings attached to it are Cardiovascular System, Diabetes Mellitus, Type 2, Hypoglycemic Agents, Insulin Glargine and Insulin, Long-Acting.

The authors tagged it with the keywords Interim analysis, cardiovascular outcomes trials, data access management plan, insulin degludec and insulin glargine U100.

What This Means in Plain Language

The paper is a randomized and double-blind study of Insulin Glargine.

The abstract goes on to report its results in about 4 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2019 (Therapeutic innovation & regulatory science), a journal based in Switzerland.

More context: the Insulin Glargine compound page.