Use of NPH Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia

Plain-language guide to NCT03511521: phase 4 randomized trial of Insulin Glargine and Insulin Aspart, insulin resistance, prediabetes & type 2 diabetes, 3 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT03511521
Phase: phase 4
Status: terminated early
Start: 2018-03-27
Completion (planned or actual): 2019-08-15
Participants: 3 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Hyperglycemia Steroid-induced; Insulin Resistance, Diabetes
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine and Insulin Aspart for insulin resistance, prediabetes & type 2 diabetes.

In both the inpatient and outpatient setting, steroids are used for their anti-inflammatory property to treat a variety of conditions.

There is a paucity of information regarding the best way to treat steroid-induced hyperglycemia.

It had two arms (groups): NPH Insulin (experimental) and Basal/Bolus Insulin (active comparator).

The registry classes the interventions as drug.

More on the Plan

Glycemic control and the incidence of hypoglycemia will be assessed over the first 3 days after initiating these insulin regimens.

Who Took Part

3 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: Diabetic and nondiabetic patients. Expected duration of hospital stay and time on steroids \>= 3 days. Patient of appropriate caregiver able to give Informed Consent.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: steroids other than methylprednisolone or prednisone.

How the Study Was Run

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

The insulin resistance, prediabetes & type 2 diabetes 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.

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

It started in 2018-03-27 with completion listed for 2019-08-15.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Glycemic Control (time frame: 3 days).

It also tracked 2 secondary outcomes, for example Percentage of Glucose Values Within Therapeutic Range and Percentage of Glucose Values Within the Hypoglycemic Range.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Aspart in 3 people with insulin resistance, prediabetes & type 2 diabetes.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); 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, Insulin resistance, prediabetes & type 2 diabetes research.

Our Notes on the Compounds

Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.

Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.

NPH Insulin (isophane): An intermediate-acting insulin made by combining insulin with protamine; also called isophane or NPH insulin (Humulin N, Novolin N).

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.