Comparison of Insulin Glargine and NPH Human Insulin in Progression of Diabetic Retinopathy in Type 2 Diabetic Patients

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine for diabetic retinopathy and glaucoma.

To compare the progression of diabetic retinopathy in type 2 diabetic patients with mild-to-moderate diabetic retinopathy treated with insulin glargine vs NPH human insulin.

The registry classes the interventions as drug.

More on the Plan

Randomized, open-label assignment of type 2 patients who are on a stable antidiabetic regimen to treatment with either insulin glargine or BID NPH human insulin, with baseline diabetic retinopathy of severity 53/\<53 on the ETDRS scale, for 5 years of followup.

Outcomes measured by seven-field fundus photography at baseline, 1.5, 3,6,and 9 months, and annually.

Who Took Part

1024 actual participants took part.

It was open to people of any sex aged from 30 years up to 70 years.

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

Examples of who could join: Type 2 diabetes mellitus for at least 1 year. Baseline retinopathy severity not to exceed 53/\<53 on the ETDRS scale. Unlikely to require laser surgery or vitrectomy within upcoming year.

The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: prior treatment with insulin glargine; treatment with insulin analogs (eg insulin lispro or aspart) in the year prior to enrollment.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The diabetic retinopathy and glaucoma participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

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

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

It started in 2001-06 with completion listed for 2007-04.

It ran at 2 sites in United States (1) and Canada (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The percentage of patients with a 3-step or greater progression in the patient. level recoded integer ETDRS retinopathy scale.

It also tracked 4 secondary outcomes, for example the distribution of patients on the patient level recoded integer ETDRS retiopathy scale, the change from baseline in HbA1c and fasting plasma glucose and the incidence of hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 1024 people with diabetic retinopathy and glaucoma.

With 1024 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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