Effects of Intensive Bolus Intravenous Insulin Delivery on Metabolic Integrity in Type 1 and Type 2 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Aspart and Insulin Lispro.

Baseline and periodic diagnostic tests are performed and questionnaires completed to evaluate and monitor progress and outcomes.

It had 1 arm (groups): IV bolus insulin, metabolic integrity (experimental).

The registry classes the interventions as procedure.

More on the Plan

It is known that the glucose metabolic pathway is the primary fuel generator to the brain, nerve tissue, heart, vascular tissue, eyes, kidneys and the liver.

Deficient metabolism state as seen in the glucose metabolism experienced in many diabetic patients can lead to complications.

The respiratory quotient (RQ) is a measurement of CO2 exhaled and O2 inhaled and is proportionate to the fuel sources being used by the body, primarily the liver over short periods of time.

The higher the RQ, the more glucose and less alternative fuel sources are being utilized.

Who Took Part

The registry lists 2000 planned participants were the target.

It was open to people of any sex aged from 18 years up to 95 years.

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

Examples of who could join: Ability to swallow without difficulty. Orthostatic hypotension due to autonomic neuropathy of advanced diabetes. Advanced gut neuropathy with gastroparesis or diabetic diarrhea. Non-healing diabetic wounds.

The full record lists 11 inclusion and 11 exclusion criteria; among the exclusions: lack of intravenous access; inability to breathe into a respiratory quotient machine; subjects on dialysis.

How the Study Was Run

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

Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2009-11 with completion listed for 2014-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Insulin Aspart and Insulin Lispro in 2000 people.

With 2000 participants it is a large trial for this field.

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

More context: the Insulin Aspart compound page and the Insulin Lispro compound page, all human trials.