Effects of Pulsatile Intravenous Insulin Therapy on Metabolic Integrity in Patients With Diabetes Mellitus

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Insulin (regular human) and Insulin Aspart.

Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion.

It had two arms (groups): 1 (no intervention) and Pulsatile Intravenous Insulin Therapy (active comparator).

The registry classes the interventions as procedure.

More on the Plan

This has been correlated with a stabilization of kidney function in patients with overt diabetic nephropathy, stabilization of blood glucoses, stabilization of blood pressure patterns, and reversal of hypoglycemic unawareness.

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

In addition the use of oral carbohydrate at the same time along with the physiologic insulin administration stimulates the appropriate gut hormones which augment this effect, a response which cannot be duplicated with intravenous glucose.

The RQ is determined by the use of a metabolic cart.

Who Took Part

The registry lists 152 actual participants took part.

It was open to people of any sex aged from 21 years up to 85 years.

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

Examples of who could join: Taking oral agents and/or insulin for diabetic control. Ability to swallow without difficulty. Ability to perform Respiratory Quotient requirements by breathing into a mask for 3 minutes at a time.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: lack of intravenous access; alcohol abuse, drug addiction or the use of illegal drugs; active liver disease.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

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

It started in 2006-11 with completion listed for 2009-08.

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 2, phase 3, non-randomized trial of Insulin (regular human) and Insulin Aspart in 152 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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