IDegLira HIGH Trial

What Was Tested

This registered phase 3 trial tested Insulin Aspart.

Thus, there is a critical need for a simpler treatment regimen that could overcome these limitations.

It had two arms (groups): IDegLira (experimental) and Basal-Bolus Insulin (active comparator).

Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.

Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.

The registry classes the interventions as drug.

More on the Plan

Sustained hyperglycemia, also known as glucotoxicity, leads to progressive loss of beta-cell function and is considered a key pathophysiological process in the development of type 2 diabetes (T2D).

Patients with severe hyperglycemia may respond poorly to oral anti-diabetic agents (OAD) alone initially and frequently require insulin to achieve glycemic targets.

Who Took Part

The registry lists 145 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Type 2 diabetes, diagnosed for ≥ 6 months. Body mass index (BMI) ≤ 45 Kg/m2.

The full record lists 4 inclusion and 21 exclusion criteria; among the exclusions: subjects with type 1 diabetes or latent autoimmune diabetes of adults (lada) (positive glutamic acid decarboxylase (gad-65) antibody and/or ketones); previous treatment with glucagon-like peptide-1 (glp-1) agonists (during prior 3 months); previous treatment with basal-bolus insulin (within prior 3 months).

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

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

It started in 2019-01-15 with completion listed for 2022-07-08.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 26).

It also tracked 26 secondary outcomes, for example Average Fasting Blood Glucose, Average Daily Blood Glucose, Number of Participants With Documented Symptomatic Hypoglycemic Events, Asymptomatic Hypoglycemic Events, Number of Participants With Severe Hypoglycemic Events and Nocturnal Symptomatic Hypoglycemic Events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 145 people.

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

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