Improving Metabolic Assessments in Type 1 Diabetes Mellitus Clinical Trials

What Was Tested

The trial (not phased) is built around Glucagon.

These two tests will be compared to assess the relationship between the MMTT and IV (intravenous) Glucagon stimulated C-peptide responses as measured by time to peak C-peptide and AUC (area under the curve) values.

The registry classes the interventions as procedure.

More on the Plan

Each participant will undergo four tests within a limited period according to the test sequence assignment.

The tests will randomly start with either MMTT or GST.

GST) and to compare the participant and investigator burden to conduct the MMTT and Glucagon tests.

TEST INFORMATION: * Mixed Meal Tolerance Test (MMTT): BOOST is a liquid meal (like a milkshake) containing a standard amount of fat, protein, and carbohydrate.

Who Took Part

Enrollment: 120 planned participants were the target.

It was open to people of any sex aged from 8 years up to 35 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 8 - 35 years at the time of inclusion. Body weight \> 30 kg. Must maintain good glycemic control.

The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: actual treatment with drugs influencing beta cell function (e.g. oral hypoglycaemic agents, beta-2-receptor agonists); actual treatment with drugs influencing insulin sensitivity (e.g. steroids); expected poor compliance.

How the Study Was Run

Design: randomized, crossover and open-label.

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

Each person switched between Glucagon and the comparison at some point, usually with a gap in between.

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

It started in 2004-11 with completion listed for 2005-11.

It ran at 18 sites in United States (13), Australia (1), Canada (1), Finland (1), Italy (1) and United Kingdom (1).

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: Stimulated C-peptide response derived from the 2-hour MMTT and the glucagon stimulation test (GST). Time to peak C-peptide on MMTT, and the peak and AUC values from each test. Co-efficient of reproducibility of the MMTT, and the GST, provided from the duplicate tests within the same individuals.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glucagon in 120 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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