Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes

What Was Tested

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

It had two arms (groups): one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

The management of patients with Type 2 diabetes involves treatment with two different types of insulin injections to control blood sugar levels.

Who Took Part

226 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Subjects admitted to the hospital with acute or chronic medical illnesses or for elective and emergency surgical illness or trauma. Known history of Type 2 diabetes mellitus for \>3 months. Treated with either diet alone, any combination of oral antidiabetic agents, non-insulin injectables or insulin therapy.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: hyperglycemia without a history of diabetes; subjects with acute critical illness admitted to the icu or expected to require icu admission; subjects receiving continuous insulin infusion.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2015-10 with completion listed for 2019-12-11.

It ran at 2 sites in United States (2).

Its stated primary purpose is health services research.

What Was Measured

The main thing measured (primary outcome): Mean Daily BG Levels (time frame: 5 days (average time of discharge from the hospital)).

It also tracked 10 secondary outcomes, for example Mean Blood Glucose Levels Before Lunch, Mean Blood Glucose Levels at Bedtime, Mean Blood Glucose Levels Before Dinner, Number of Hypoglycemia Events, Incidence of Hyperglycemia and Average Number of Days of Hospital Stay.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Aspart in 226 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.