Comparison of Diabetes Retinopathy Among Type 2 Diabetic Patients Treated With Different Regimens

What Was Tested

In this early phase 1 trial, researchers set out to test Insulin Glargine for diabetic retinopathy and glaucoma.

Diabetic retinopathy (DR) is an important cause of blindness.

It had three arms (groups): oral drugs (experimental), lantus (experimental) and Novomix30 (experimental).

The registry classes the interventions as drug.

More on the Plan

Diabetic retinopathy (DR) is an important cause of blindness, and its development of an irreversible process.

In this study, three different glucose-lowering program for: (A) a single oral anti-diabetic drugs, (B) basal insulin and oral anti-diabetic drugs, (C) premixed insulin and oral anti-diabetic drugs for comparison.

Focus on the stability and the impact of these three programs hypoglycemic long-term prognosis of the DR, and thus affect the molecular mechanisms of DR-based exploration of glucose fluctuations, to optimize blood glucose solutions, lower blood sugar steady, slow progression of DR ultimate clinical purposes.

The multi-center study is to cooperate, enrolled 600 cases of type 2 diabetes, observe the effects of different solutions on blood sugar glucose fluctuations and retinopathy, a total of 5 years of follow-up.

Who Took Part

The registry lists 600 planned participants were the target.

It was open to people of any sex aged from 30 years up to 65 years.

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

Examples of who could join: Diagnosed to be type 2 diabetes in accordance with the WHO diagnostic criteria in 1999 . Diabetes duration for 5 years or less;. Body mass index (BMI) 20-35 kg/m2;. Women of childbearing-age have birth control plan for 5 years plan;.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: pregnant or lactating women;; diabetes autoantibodies (gad) antibodies positive;; occurred state of diabetic ketoacidosis, diabetes, high permeability, diabetes lactic acidosis within a half years ;.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Insulin Glargine study: the diabetic retinopathy and glaucoma participants and staff both knew the treatment.

It started in 2015-07 with completion listed for 2023-07.

It ran at 1 site in China.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): The incidence of diabetic retinopathy (time frame: 5years).

It also tracked 4 secondary outcomes, for example cardiovascular events, renal failure, glucose fluctuation and oxidative stress.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Insulin Glargine in 600 people with diabetic retinopathy and glaucoma.

With 600 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 Glargine compound page, Diabetic retinopathy and glaucoma research.