Lantus Effect on Myocardial Glucose Metabolism in T2

What Was Tested

The trial (phase 4) is built around Insulin Glargine.

The primary objective of the present study is to assess changes of myocardial glucose uptake (MGU) during clamp studies using positron emission tomography (PET) scanning in patients with type 2 diabetes and idiopathic left ventricular dysfunction (LVD).

The secondary objectives of the study are: assessment of changes of myocardial microcirculation at rest and during adenosine stimulation using PET; assessment of changes in myocardial structure and function evaluated by magnetic resonance imaging (MRI); assessment of glycaemic control by measurement of HbA1c, fasting blood glucose and insulin levels; assessment of safety (adverse event profile, laboratory data).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 15 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Newly diagnosed type 2 diabetes;.

The full record lists 4 inclusion and 25 exclusion criteria; among the exclusions: evidence of congenital or valvular cardiac diseases, hypertrophic cardiomyopathy, overt heart failure (nyha class iii-iv);; moderate to severe hypertension (diastolic aortic pressure \> 100 mmhg);; hypotension (systolic aortic pressure \< 100 mmhg);.

How the Study Was Run

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

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.

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

It started in 2005-09 with completion listed for 2008-06.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: effect of insulin treatment on myocardial function, perfusion and glucose metabolism (time frame: assessed before and after treatment). adverse events (time frame: throughout the study).

It also tracked 1 secondary outcome, for example changes of myocardial structure and left ventricular systolic and diastolic function.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Insulin Glargine in 15 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.