Human Insulin Analogs: Evaluation of Inflammatory mRNA Expression of Macrophages and Endothelial Function of Short-acting Insulin - HERMES Pilot Study

What Was Tested

The trial (phase 4) is built around Insulin (regular human) and Insulin Aspart.

The primary parameter in this study are the postprandial changes in the nitrotyrosine concentrations, a biomarker for oxidative stress.

As vascular data on Insulin Glulisine vs.

It had three arms (groups): Insulin Glulisine: bolus injections before each main meal (experimental), Insulin Aspart: bolus injections before each main meal (active comparator) and Regular human insulin:bolus injections before each main meal (active comparator).

Patients are already on an Insulin Glargine therapy when they start and will them after randomization receive additionally Insulin Glulisine bolus injections before each of the main meals.

Patients are already on an Insulin Glargine ± metformin therapy when they start the start and will them after randomization receive additionally Insulin Aspart bolus injections before each of the main meals.

Patients are already on an Insulin Glargine ± metformin therapy when they start the start and will them after randomization receive additionally regular human insulin bolus injections before each of the main meals.

The registry classes the interventions as drug.

Who Took Part

The registry lists 12 planned participants were the target.

It was open to people of any sex aged from 30 years up to 75 years.

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

Examples of who could join: Type 2 diabetes mellitus. Stable BOT (basal oral therapy) with Insulin Glargine + ≥ 2 OHA (oral hypoglycemic agents except for TZD) for a minimum of three months before entering the study. Age between 30 and 75 years inclusively. Body mass index ≤ 40 kg/m2. Patient consents that his/her family physician will be informed of trial participation.

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: type 1 diabetes mellitus; use of thiazolidinediones within the last 3 months prior to study start; history of drug or alcohol abuse within the last five years prior to screening.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

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

It started in 2011-09 with completion listed for 2012-05.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Nitrotyrosine (time frame: Baseline, after 10 weeks, after 24 weeks).

It also tracked 7 secondary outcomes, for example Skin blood flow, mRNA expression of proinflammatory cytokines (MAPK/eNOS, adiponectin, hsCRP, MMP-9), Insulin, HbA1c, Fasting blood glucose and Hypoglycemic events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Insulin Aspart in 12 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page and the Insulin Aspart compound page, all human trials.