Outcome of Glargine Insulin in Renal Impairment Patients With Diabetic Ketoacidosis

What Was Tested

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

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

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 52 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Male and female patients. Type I and type II diabetes mellitus. Patients on insulin and/or oral hypoglycemic therapy. Duration of diabetes more than 5 years. Medical and surgical patients.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: acute myocardial infarction; liver cell failure; need for emergency surgery.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and outcomes assessor.

It started in 2020-12-01 with completion listed for 2022-06.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean time to reversal of diabetic ketoacidosis (time frame: 48 hours). Total crystalline insulin consumption (time frame: 48 hours).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Glargine in 52 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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