Insulin Effects on Cardiac Function in Patients With Diabetes Mellitus

What Was Tested

This registered phase 4 trial tested Insulin Lispro.

Each subject was evaluated for glucose homeostatic, hemodynamic and echocardiographic systolic and diastolic parameters at baseline and following two successive insulin-load steps of a euglycemic hyperinsulinemic clamp study, each 2 h in duration.

It had 1 arm (groups): Diabetic patients (experimental).

The registry classes the interventions as drug.

More on the Plan

Patients' characteristics are summarized in table 1.

Each patient served as his or her own control.

Prior to the study, patients gave written informed consent after receiving a detailed explanation as to the purpose of the study, the technique, its side effects and the study protocol.

Glucose consumption rates against changing insulin levels were measured by the EHC technique.

Who Took Part

The registry lists 6 actual participants took part.

It was open to men only aged from 30 years up to 65 years.

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

Examples of who could join: Diabetes mellitus duration of 2 years and over.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: previous cardiac disease: valvular, pacing, arrhythmias, primary cardiomyopathy.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Insulin Lispro study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2003-02 with completion listed for 2003-05.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Left ventricle ejection fraction (%) (time frame: 1 year).

It also tracked 1 secondary outcome, for example Time needed to exert insulin effect on myocardial function (hour).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Insulin Lispro in 6 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 Lispro compound page, all human trials.