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Intensive Versus Conventional Hyperglycemic Control in Hospitalized Non-critically Ill Patients

Plain-language guide to NCT03510078: not phased randomized trial of Insulin (regular human), 600 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03510078
Phase
not phased
Status
completed
Start
2018-04-17
Completion (planned or actual)
2025-07-01
Participants
600 (actual)
Design
randomized, double-blind, treatment
Conditions studied
Diabetes Mellitus; Non-critically Ill Patients
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Insulin (regular human).

Hyperglycemia is a common condition among hospitalized patients.

It had two arms (groups): Intensive glycemic control (experimental) and Conventional glycemic control (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 600 actual participants took part.

It was open to people of any sex aged from 18 years up to 120 years.

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

Examples of who could join: Age older than 18 years old. A minimum of three days of hospitalization.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: diabetic ketoacidosis or hyperosmolar non-ketotic state; patients expected to require intensive care unit admission or immediate surgical intervention; history of current drug or alcohol abuse.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this Insulin (regular human) 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.

Blinding on both sides kept the participants and researchers unaware of who received Insulin (regular human).

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2018-04-17 with completion listed for 2025-07-01.

It ran at 5 sites in Israel (4) and Italy (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Composite outcome of: 1. mortality in 30 days (time frame: 30 days). Severe hypoglycemia (time frame: 30 days). Severe infections (time frame: 30 days).

It also tracked 4 secondary outcomes, for example Each component of the primary outcomes, Repeat hospitalizations within 90 days, Severe infections within 90 days and Length of hospitalization.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 600 people.

With 600 participants it is a large trial for this field.

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

More context: the Insulin (regular human) compound page, all human trials.

Our Notes on the Compound

Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.

Related Pages

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.