Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial

What Was Tested

Researchers studied Insulin Glargine and Liraglutide in this randomized controlled trial publication.

Who Took Part

The study group was 581 patients.

By PubMed's age tags, the people studied were teenagers, young adults, adults, middle-aged adults, older adults and people over 80, both men and women.

Investigators, participants and study monitors were blinded to the treatment status of the liraglutide and placebo groups at all times.

How the Study Was Run

The design is described as randomized, open-label, placebo-controlled and parallel-group.

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

Being open-label, the Insulin Glargine study did not mask who received what.

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.

The primary endpoint was HbA(1c).

What Was Measured

Topics PubMed links to this paper include Blood Glucose, Diabetes Mellitus, Type 2, Glucagon-Like Peptide 1, Hypoglycemic Agents, Insulin, Insulin Glargine and Insulin, Long-Acting.

What This Means in Plain Language

The paper is a randomized, open-label and placebo-controlled study of Insulin Glargine and Liraglutide in 581 patients.

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

The abstract goes on to report its results in about 8 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2009 (Diabetologia), a journal based in Germany.

More context: the Insulin Glargine compound page and the Liraglutide compound page.