Degludec Glargine U300 Hospital Study

What Was Tested

In this not phased trial, researchers set out to test Insulin Glargine.

Limited data exist about the use of insulin degludec and insulin glargine U300 in the hospitalized patients.

It had two arms (groups): Degludec (experimental) and Glargine U300 (active comparator).

The registry classes the interventions as drug.

More on the Plan

The purpose of this study is to find out if treatment with insulin degludec when compared to insulin glargine U300 will result in similar blood sugar control in hospitalized patients with type 2 diabetes.

Change in mean daily blood glucose concentration in hospitalized patients \[ Time Frame: The first 7 days of therapy \] Blood glucose will be measured before each meal, bedtime and at 3:00 am.

Mean daily blood glucose concentration will be calculated to determine differences in inpatient glycemic control in patients with type 2 diabetes treated with basal bolus regimen or basal plus regimen with insulin degludec or glargine U300 once daily plus insulin glulisine before meals.

Average blood glucose (mg/dl), percentage time in target, percentage time below target, and percentage time above target in a subgroup of study participants A subgroup of participants (n = 100) will be monitored using continuous glucose monitoring system (CGMS) (FreeStyle Libre).

Who Took Part

220 actual participants took part.

It was open to people of any sex aged from 30 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 30 years or above admitted to the hospital for elective CABG surgery. A known history of type 2 diabetes treated with any combination of oral antidiabetic agents, short-acting GLP1-RA (exenatide, liraglutide) or insulin therapy except for degludec and glargine U300. Signed, informed consent prior to any study procedures.

The full record lists 4 inclusion and 8 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 glp1-ra (weekly exenatide, or dulaglutide); patients with medical and surgical pancreatic disease.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

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 2021-10-10 with completion listed for 2022-03-01.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in mean daily blood glucose concentration in hospitalized patients (time frame: The first 7 days of therapy).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Glargine in 220 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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