LEADER 2: baseline calcitonin in 9340 people with type 2 diabetes enrolled in the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial: preliminary observations

What Was Tested

Researchers studied Calcitonin and Liraglutide in this randomized controlled trial publication.

To report preliminary data on baseline serum calcitonin concentrations and associated clinical characteristics in a global population with type 2 diabetes before liraglutide or placebo randomization.

Who Took Part

The abstract describes 9340 people taking part.

PubMed indexes the participants as middle-aged adults and older adults, both men and women.

The ongoing LEADER trial has enrolled 9340 people with type 2 diabetes and at high risk of cardiovascular disease at 410 centres worldwide.

How the Study Was Run

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

The people were allocated by chance, so the Calcitonin group and the comparison group should start out alike.

Neither the people nor the staff measuring them knew who was on Calcitonin, so expectations could not easily colour the readings.

Some people received a placebo instead of Calcitonin, giving a reference point.

The timeline in the abstract includes 5 years.

People with baseline serum calcitonin ≤ 50 ng/l were randomized to liraglutide once daily or placebo and will be followed for up to 5 years.

Serum calcitonin was measured at baseline and will be measured annually thereafter.

An independent committee of thyroid experts will oversee calcitonin monitoring throughout the trial and will review all calcitonin concentrations ≥ 20 ng/l.

What Was Measured

PubMed files the paper under topics including Body Mass Index, Calcitonin, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Glomerular Filtration Rate, Hypoglycemic Agents and Linear Models.

Author keywords: c-cell disease and incretins.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Calcitonin and Liraglutide in 9340 people over 5 years.

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

Its findings take up roughly 6 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2015 (Diabetes, obesity & metabolism), a journal based in England.

More context: the Calcitonin compound page and the Liraglutide compound page.