Insulin Glargine U300 vs Insulin Degludec U100 in Impact on the Glycaemic and Cardiovascular Factors

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

To compare the impact of insulin degludec (IDeg-100) and insulin glargine U300 (IGlar-300) on cardiovascular risk parameters - glycaemic variability (GV), oxidative stress, arterial stiffness and lipid parameters - in insulin naive patients with DMT2.

It had two arms (groups): degludec arm (active comparator) and glargine arm (active comparator).

The registry classes the interventions as drug.

More on the Plan

The researchers recruited a total of 25 patients (23 completed the study) with T2DM who had uncontrolled disease on two or more oral antidiabetic drugs.

After the wash-up period, they were randomized alternately to first receive either IDeg-100 or IGlar-300 along with metformin.

Each insulin was applied for 12 weeks.

At the beginning and the end of each phase, biochemical and oxidative stress parameters were analysed and augmentation index was measured.

Who Took Part

The registry lists 25 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: A history of DMT2 for at least 1 year. Aged between 18 and 65 years (women obligatory postmenopausal). Uncontrolled glycaemia on two or more oral antidiabetic drugs. No prior use of insulin. Receiving statins (if not on statins, they were put on it).

The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: the presence of malignant disease; chronic liver disease; severe cardiovascular disease or history of cardiovascular incidents (stroke, myocardial infarction, peripheral amputation).

How the Study Was Run

It was run as a randomized, crossover and open-label study.

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

Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2018-12-15 with completion listed for 2019-06-27.

It ran at 1 site in Croatia.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Changes from baseline in glucose variability (time frame: 3 months). Changes from baseline in oxidative stress (time frame: 3 months). Changes from baseline in arterial stiffness after treatment (time frame: 3 months).

It also tracked 14 secondary outcomes, for example Changes from baseline in total cholesterol, Changes from baseline in triglycerides, Changes from baseline in LDL, Changes from baseline in HDL, Changes from baseline in WBC and Changes from baseline in RBC.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 25 people.

Its size is small, so on its own it can only give an early look.

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, all human trials.