Glargine U300 Hospital Trial

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine.

The purpose of this study is to find out if treatment with Glargine U300 when compared to Glargine U100 will result in similar sugar control in patients with Type 2 Diabetes (T2D), who are admitted to the hospital and then transition at home, after discharge from the hospital.

It had two arms (groups): Basal bolus insulin with glargine U300 and glulisine insulin (experimental) and Basal bolus insulin with glargine U100 and glulisine insulin (active comparator).

The registry classes the interventions as drug.

More on the Plan

This study will determine if treatment with glargine U300 has a similar glucose control in patients with diabetes admitted to the hospital and if glargine U300 will result in lower number of low blood sugars compared to glargine U100 .

Who Took Part

The registry lists 247 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Males or females between \> 18 years admitted to a general medicine or surgical service.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: patients treated with degludec or glargine u300, or with long-acting weekly glp1-ra (weekly exenatide, dulaglutide or albiglutide); patients with acute critical or surgical illness admitted to the icu or expected to require admission to the icu; mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

How the Study Was Run

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

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

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

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2017-05-17 with completion listed for 2019-03-22.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean Daily Blood Glucose Concentration Inpatient (time frame: up to 10 days (day of hospital discharge)). Mean Daily Blood Glucose Concentration After Hospital Discharge (time frame: assessed from day 11 (day after hospital discharge) up to 3 months).

It also tracked 12 secondary outcomes, for example Mean Daily Glucose in Patients With Length of Stay Shorter Than 3 Days, Mean Daily Glucose in Patients With Length of Stay Shorter Than 5 Days, Mean Daily Glucose in Patients With Length of Stay Longer Than 5 Days, Percent of Blood Glucose 70-180 Measured by Point of Care Test, Percent of Subjects With Hypoglycemic Events and Percent of Subjects With Severe Hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 247 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, all human trials.