[Efficacy and safety of ultra rapid lispro in the treatment of type 2 diabetes mellitus: a randomized controlled clinical trial]

What Was Tested

Researchers studied Insulin Lispro in this randomized controlled trial publication.

Methods: This was an international multicenter, double-blind, randomized controlled study.

The primary endpoint was the change in hemoglobin A1c (HbA1c) relative to baseline after 26 weeks of treatment.

Who Took Part

The abstract describes 481 patients taking part.

PubMed tags the participants as men only.

From May 2019 to January 2021, a total of 481 patients with type 2 diabetes mellitus, who had been using insulin for at least 90 days and had poor glycemic control, were included.

These patients were recruited from 34 research centers in China, including Shanghai Jiao Tong University School of Medicine Affiliated Sixth People's Hospital.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin Lispro and who got the comparison, which limits bias.

Neither the patients nor the staff measuring them knew who was on Insulin Lispro, so expectations could not easily colour the readings.

More than one site took part, so the patients came from several places.

They were assigned to either the URLi group (319 patients) or the HL group (162 patients) using stratified blocked randomization.

What Was Measured

The primary endpoint was the change in hemoglobin A1c (HbA1c) relative to baseline after 26 weeks of treatment.

Continuous variables were compared using mixed model repeated measures or analysis of covariance, and categorical variables were compared using logistic regression or Fisher's exact test.

PubMed files the paper under topics including Insulin Lispro, Diabetes Mellitus, Type 2, China, Glucose and Hypoglycemia.

What This Means in Plain Language

The paper is a randomized, double-blind and multicenter study of Insulin Lispro in 481 patients.

With several hundred people or more, it is a fairly large study for this kind of research.

The publication is from 2023 (Zhonghua nei ke za zhi), a journal based in China.

More context: the Insulin Lispro compound page, all human trials.