Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With T2D

What Was Tested

In this phase 4 trial, researchers set out to test Semaglutide and Insulin Aspart.

It had two arms (groups): Once-weekly sc semaglutide combined with once-daily insulin (experimental) and MDI requiring multiple daily injections of insulin (experimental).

Patients randomized to continue with MDI will be transitioned from their existing regimen to the rapid-acting insulin product insulin aspart and their basal insulin switched to once-daily insulin degludec.

The registry classes the interventions as drug.

More on the Plan

Patients with type-2 diabetes mellitus (T2D) are often overweight or obese.

In order to obtain adequate glycemic control, many of these patients require intensive therapy with multiple daily injections of insulin (referred to as MDI, basal/bolus regimen), using a rapid-acting/bolus insulin at each meal in combination with a once- or twice-daily long- acting/basal insulin.

Unfortunately, intensive insulin therapy can result in undesired weight gain, which may, in part, result in further insulin resistance.

In addition, weight gain may adversely affect the control of comorbid health conditions (hypertension, hyperlipidemia, congestive heart failure, sleep apnea, etc.).

Who Took Part

Enrollment: 60 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Gender: men and women. Ethnicity: all ethnic groups. Age: ≥ 18 to 75 years. Type II diabetes. Currently treated with MDI (basal/bolus regimen) for at least 6 months.

The full record lists 12 inclusion and 17 exclusion criteria; among the exclusions: GAD-65 antibody positive; known or suspected allergy to trial medication(s), excipients, or related products, i.e., glp-1ra therapy or insulin aspart or insulin degludec; the receipt of any investigational drug within 90 days prior to this trial.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2021-01-18 with completion listed for 2023-03-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Mean Weight Change, Hypoglycemic Episodes, Mean Change From Baseline in A1C and Diabetes Treatment Satisfaction Comparison Between Groups.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide and Insulin Aspart in 60 people.

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

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