Albiglutide Versus Placebo in Insulin-treated Subjects With New-onset Type 1 Diabetes Mellitus

What Was Tested

The trial (phase 2) is built around Insulin (regular human).

This is a Phase II, randomized, double-blind, parallel group, placebo controlled, multicentre study of 52 weeks treatment duration.

It had two arms (groups): Albiglutide (experimental) and Placebo (experimental).

Approximately 17 subjects will be assigned to albiglutide matching placebo + background insulin.

The registry classes the interventions as biological.

Who Took Part

The registry lists 67 actual participants took part.

It was open to people of any sex aged from 18 years up to 30 years.

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

Examples of who could join: Body mass index \<=32.0 kilogram/square meters (kg/m\^2). Able and willing to provide written informed consent and to comply with all study procedures.

The full record lists 7 inclusion and 16 exclusion criteria; among the exclusions: severe gastroparesis i.e., requiring therapy within 6 months prior to screening; personal history or family history of thyroid medullary carcinoma or multiple endocrine neoplasia type 2 (men2); haemoglobinopathy that may affect proper interpretation of hba1c.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Insulin (regular human).

Those kept unaware of assignments: participant and investigator.

It started in 2014-10-10 with completion listed for 2017-10-18.

It ran at 32 sites in Spain (11), United Kingdom (11), Germany (4), France (3) and Italy (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean Change From Baseline in Time Normalized Stimulated (From Mixed Meal Tolerance Test [MMTT]) 2-hour Plasma C-peptide Area Under the Curve (AUC) at Week 52 (time frame: Baseline and Week 52).

It also tracked 19 secondary outcomes, for example Mean Change From Baseline in Time Normalized Stimulated (From MMTT) 2 Hour Plasma C-peptide AUC at Week 16, 28 and Week 64, Maximum Stimulated Plasma C-peptide (MMTT) at Baseline, Week 16, 28, 52 and 64, Mean Change From Baseline in Time Normalized Plasma Glucagon AUC (From MMTT) at Week 16, 28, 52 and 64, Percentage of Responders at Baseline, Weeks 4, 8, 16, 28, 40, 52 and 64, Change From Baseline in Percent HbA1c at Week 52 and Percent HbA1c Over Time (at Weeks 4, 8, 16, 28, 40, 52 and 64).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 67 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page, all human trials.