Diabetes Islet Preservation Immune Treatment

What Was Tested

The trial (phase 1, phase 2) is built around Exenatide.

To assess whether there is a difference in endogenous insulin secretion, measured as stimulated C-peptide secretion (area under the curve during a 4-hour mixed meal tolerance test), at the 1 year visit, for study subjects receiving combinational therapy versus those receiving placebo.

The study will also examine the effect of the proposed treatments on immunological outcomes, specifically proportion of regulatory T cells at the 1 year visit.

It had two arms (groups): Arm A (experimental) and Arm B (placebo comparator).

Participants in this group will receive the placebos for Thymoglobulin, Aldesleukin, Adalimumab, Exenatide, and Neulasta over a period of 52 weeks.

The registry classes the interventions as drug and other.

Who Took Part

It was open to people of any sex aged from 18 years up to 35 years.

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

Examples of who could join: Patients must meet all of the following criteria to be eligible to participate in this study:. Subject must be able to understand and provide informed consent. Males and females, 18-35 years of age. New onset T1D for no longer than 120 days at the time of randomization. Being on insulin therapy.

The full record lists 10 inclusion and 20 exclusion criteria; among the exclusions: potential participants must not meet any of the following exclusion criteria:; inability or unwillingness of a participant to give written informed consent or comply with study protocol; BMI\>30 Kg/m2.

How the Study Was Run

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

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Exenatide group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2024-06-01 with completion listed for 2024-06-01.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Simulated C-peptide AUC (time frame: 1 Year Visit). Proportion of regulatory T cells (time frame: 1 Year Visit).

It also tracked 4 secondary outcomes, for example Hemoglobin A1c (HbA1c) levels, Mean daily plasma glucose levels and Incidence of immune response adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Exenatide in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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