Insulin Degludec and Glargine U100 for Management of Hospitalized and Discharged Patients With Type 2 Diabetes

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

The purpose of this study is to find out if treatment with degludec insulin when compared to glargine U100 insulin will result in similar blood sugar control in patients with diabetes who are admitted to the hospital and then transition to home after discharge from the hospital.

It had two arms (groups): Degludec inpatient (experimental) and Glargine U100 inpatient (active comparator).

The registry classes the interventions as drug.

More on the Plan

Degludec is a new generation basal insulin analog with a longer duration of action compared to insulin glargine.

Participants will be randomized to receive either a basal bolus with degludec or glargine U100 once daily during hospitalization.

All participants will receive aspart insulin before meals.

Participants with poorly controlled diabetes during the inpatient portion of the study will be invited to participate in the outpatient portion of the study.

Who Took Part

The registry lists 180 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 \> 18 years of age who are admitted to a general medicine or surgical service. Medical and surgical patients expected to be admitted length of stay (LOS) longer than 2 days. Signed, informed consent and HIPAA documentation prior to any study procedures.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria; patients treated with degludec or glargine u300, or with long-acting weekly glp-1 ra (weekly exenatide, dulaglutide or albiglutide); patients with acute critical or surgical illness admitted to the icu except for observation (\<24 hours and did not require vasopressors and/or mechanical ventilation).

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.

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

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 2018-01-02 with completion listed for 2021-03-01.

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

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean Daily Blood Glucose Concentration in Hospitalized Patients (time frame: Baseline, up to the first 10 days of therapy). Mean Daily Blood Glucose Concentration in Discharged Patients (time frame: Day after hospital discharge to 4 weeks after discharge, 4 to 12 weeks after hospital discharge).

It also tracked 10 secondary outcomes, for example Number of Participants With an Episode of Hypoglycemia While Hospitalized, Number of Participants With an Episode of Severe Hypoglycemia While Hospitalized, Number of Participants With an Episode of Severe Hyperglycemia While Hospitalized, Hemoglobin A1c (HbA1c) in Discharged Patients, Number of Hypoglycemia Episodes in Discharged Patients and Number of Episodes of Severe Hyperglycemia in Discharged Patients.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 180 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.