Effects of Pulsatile Intravenous Insulin Delivery on Diabetic Neuropathy in pATIENTS (Pts) With Type 1 and Type 2 Diabetes

What Was Tested

This registered phase 2, phase 3 trial tested Insulin Aspart and Insulin Lispro.

It had two arms (groups): 1 (placebo comparator) and 2 (active comparator).

Control patients with diagnosed diabetic neuropathy will receive baseline testing and testing every six months thereafter to compare and analyze results with patients treated with pulsatile intravenous insulin therapy.

Patients with diagnosed diabetic neuropathy have objective testing and questionnaires performed at baseline and every six months thereafter to evaluate and analyze progress of diabetic neuropathy after the start of pulsatile intravenous insulin therapy.

The registry classes the interventions as procedure.

More on the Plan

DN may affect the peripheral motor and sensory nerves in addition to the autonomic nervous system (1-3).

This study is designed to compare patients with DN who receive pulsatile IV insulin therapy with a control group.

Pulsatile IV insulin therapy encourages the glucose metabolism in diabetics to normalize in multiple organs, especially muscle, retina, liver, kidney and nerve endings.

The process is monitored by frequent measuring of glucose levels and respiratory quotients (RQ).

Who Took Part

It was open to people of any sex aged from 20 years up to 90 years.

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

Examples of who could join: All patients were diagnosed by their endocrinologists as having diabetic neuropathy. All patients are taking oral agents and/or insulin for diabetic control. Endocrinologist must assess and approve patient for participation in this study.

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

How the Study Was Run

Design: non-randomized, parallel-group and single-blind.

The Insulin Aspart group and the comparison group ran side by side rather than switching.

Only one side, usually the participants, was kept unaware of whether Insulin Aspart was given.

Those kept unaware of assignments: investigator.

It started in 2005-02 with completion listed for 2011-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): To evaluate objective testing performed including nerve conduction velocity in diabetic patients treated with pulsatile intravenous insulin therapy (time frame: at baseline and every six months).

It also tracked 1 secondary outcome, for example To obtain patient questionnaires and perform objective testing to analyze, compare and measure progress.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, non-randomized trial of Insulin Aspart and Insulin Lispro in people.

It was withdrawn before enrolling anyone; 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.