Effects of Pulsatile IV Insulin Delivery on Diabetic Retinopathy in Patients With Types 1 and 2 Diabetes Mellitus

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Insulin Aspart for diabetic retinopathy and glaucoma.

Diabetic Retinopathy is the leading cause of blindness in the world.

Similar pathogenetic mechanisms have been postulated for diabetic retinal disease.

It had two arms (groups): 2 (active comparator) and 1 (no intervention).

Patients diagnosed with Diabetic Retinopathy are enrolled as control patients that do not receive the pulsatile intravenous insulin therapy. Control patients come into the center receive baseline fundus photography and quarterly fundus photography to measure progress and outcomes of diabetic retinopathy and are compared to the patients who receive pulsatile intravenous insulin therapy.

The registry classes the interventions as procedure.

More on the Plan

Diabetic retinopathy is one of the leading causes of blindness in the world.

Histopathologic findings range from microaneurysms and cotton wool spots to more ominous neovascularization.

The latter process, known as proliferative diabetic retinopathy, can progress to total blindness if untreated.

Associated findings include abnormalities of vasoactive peptides such as vascular endothelial growth factor (VEGF), pigment epithelium derived factor (PEDF), and insulin-like growth factor (ILF-1), lipids, oxidative pathways, enzymatic pathways, such as protein kinase, and carbohydrate metabolism (1-4).

Who Took Part

150 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Fundus photographs will be examined by an independent retinal specialist and the patients will be stratified into the three groups as outlined above. Endocrinologist must assess and approve patient for participation in this study.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: lack of intravenous access; alcohol abuse, drug addiction or the use of illegal drugs; positive hiv.

How the Study Was Run

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

Groups ran in parallel: each of the diabetic retinopathy and glaucoma participants stayed in one arm throughout.

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

Those kept unaware of assignments: investigator.

It started in 2005-11 with completion listed for 2009-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Serial fundus photography (time frame: Stabilization of retinal blood vessel degeneration).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, non-randomized trial of Insulin Aspart in 150 people with diabetic retinopathy and glaucoma.

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

More context: the Insulin Aspart compound page, Diabetic retinopathy and glaucoma research.