Novolog vs. Fiasp Insulin in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus

What Was Tested

This registered phase 3 trial tested Insulin Glargine and Insulin Aspart.

This study examines the effects of Fiasp (a faster acting insulin) on blood sugars after meals compared to another type of insulin known as Novolog.

It had two arms (groups): Group 1 insulin glargine and Novolog (active comparator) and Group 2 insulin glargine and Fiasp (experimental).

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 137 actual participants took part.

It was open to people of any sex aged from 21 years up to 80 years.

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

Examples of who could join: Age ≥ 21 and \<= 80 years. Diagnosed with type 2 diabetes at least 180 days prior to screening. Prior to admission subjects must be using one of the following for outpatient diabetes management:. ≥ 2 oral/injectable agents. Patients who are expected to remain hospitalized for a minimum of 48 hours following CGM sensor placement.

The full record lists 13 inclusion and 16 exclusion criteria; among the exclusions: patients with a history of type 1 diabetes or late-onset autoimmune diabetes (lada); treatment or plan for treatment with glucocorticoids during the index hospitalization; female patients who are pregnant (tested during hospitalization or screening) or breast-feeding during the hospitalization.

How the Study Was Run

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

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

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

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

It started in 2020-12-07 with completion listed for 2023-05-27.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Postprandial Glucose Control (time frame: 3 days).

It also tracked 8 secondary outcomes, for example Glycemic Control While Hospitalized, Percent of Time Spent With Hypoglycemia During Hospitalization, Percent of Nocturnal Time Spent With Hypoglycemia, Percent of Postprandial Time Spent With Level 1 Hyperglycemia, Percent of Postprandial Time Spent With Level 2 Hyperglycemia and Percent of Postprandial Time Spent With Hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 137 people.

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

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