A Trial to Assess Safety and Efficacy of ADO09 Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus

What Was Tested

This registered phase 1, phase 2 trial tested Insulin Aspart.

This is a randomized, double-blind, active-controlled, 2 period cross-over clinical trial in subjects with type 1 diabetes mellitus using a Multiple Daily Injection (MDI) regimen.

It had two arms (groups): Co-formulation of insulin analog and pramlintide (ADO09) (experimental) and NovoRapid® (active comparator).

Subcutaneous injection of ADO09 formulation.

Subcutaneous injection of insulin aspart.

The registry classes the interventions as drug.

More on the Plan

After a screening visit, eligible subjects will enter a run-in period.

Subjects will receive a Continuous Glucose Monitoring (CGM) system for glucose monitoring and control at the beginning of the run-in and for the whole duration of the study.

At Day 1 a mixed meal test (MMT) will be conducted at breakfast and subjects will remain at the clinical site until day 3.

At Day 3 subjects will leave the clinical site and continue the treatment with IMP for the next 3 weeks.

Who Took Part

44 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Signed and dated informed consent obtained before any trial-related activities. Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months. Treated with insulin ≥ 12 months.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: known or suspected hypersensitivity to products used in the clinical trial; type 2 diabetes mellitus; previous participation in this trial. participation is defined as randomized.

How the Study Was Run

Design: randomized, crossover and triple-blind.

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

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

Blinding on both sides kept the participants and researchers unaware of who received Insulin Aspart.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2019-06-06 with completion listed for 2020-06-27.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): ΔAUCPG(0-4h) (time frame: From 0 to 4 hours).

It also tracked 4 secondary outcomes, for example Plasma glucose control as measured by CGM and Safety and tolerability (Adverse Events recording).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Insulin Aspart in 44 people.

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

More context: the Insulin Aspart compound page, all human trials.