Evaluation of long-term treatment effect in a type 1 diabetes intervention trial: differences after stimulation with glucagon or a mixed meal.

What Was Tested

This randomized controlled trial looks at Glucagon.

Endogenous insulin secretion, measured by C-peptide area under the curve (AUC), can be tested using both the glucagon stimulation test (GST) and the mixed-meal tolerance test (MMTT).

This study compares these two stimulation methods using long-term data from patients newly diagnosed with type 1 diabetes or with latent autoimmune diabetes.

Data from 343 patients in two balanced-randomized, double-blind, placebo-controlled, parallel-group trials of DiaPep277 were used to compare and correlate between GST- and MMTT-derived C-peptide AUC.

Who Took Part

According to the abstract, 343 patients were involved.

The age groups tagged for this paper are teenagers, young adults, adults and middle-aged adults, both men and women.

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 Glucagon and who got the comparison, which limits bias.

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

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

Groups ran in parallel: each of the patients stayed in one arm throughout.

Unexpectedly, MMTT failed to detect differences between the treated and control groups.

Pearson's correlations were calculated for absolute C-peptide AUC at baseline and 12 and 24 months and for long-term changes in AUC (AUC).

What Was Measured

PubMed files the paper under topics including Area Under Curve, Blood Glucose, C-Peptide, Chaperonin 60, Diabetes Mellitus, Type 1, Fasting and Food.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Glucagon in 343 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 4 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2014 (Diabetes care), a journal based in United States.

More context: the Glucagon compound page, all human trials.