Efficacy and safety of oral basal insulin versus subcutaneous insulin glargine in type 2 diabetes: a randomised, double-blind, phase 2 trial

What Was Tested

The paper reports a study of Insulin Glargine, published as a randomized controlled trial.

Oral insulin 338 (I338) is a long-acting, basal insulin analogue formulated in a tablet with the absorption-enhancer sodium caprate.

Who Took Part

By PubMed's age tags, the people studied were adults, middle-aged adults and older adults, both men and women.

Randomisation occurred by interactive web response system stratified by baseline treatment with oral antidiabetic drugs.

Patients and investigators were masked to treatment assignment.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled and parallel-group study.

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

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

The comparison arm used a placebo, so changes seen with Insulin Glargine could be set against what happens without it.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

This was a phase 2, 8-week, randomised, double-blind, double-dummy, active-controlled, parallel trial completed at two research institutes in Germany.

The trial has been completed and is registered at ClinicalTrials.gov, number NCT02470039.

What Was Measured

PubMed files the paper under topics including Biomarkers, Blood Glucose, Diabetes Mellitus, Type 2, Glycated Hemoglobin, Hypoglycemic Agents, Insulin and Insulin Glargine.

What This Means in Plain Language

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

The abstract goes on to report its results in about 12 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2019 (The lancet. Diabetes & endocrinology), a journal based in England.

More context: the Insulin Glargine compound page.