INSUlin Regimens and VASCular Functions

What Was Tested

In this not phased trial, researchers set out to test Insulin (regular human) and Insulin Detemir.

Vago-sympathetic activity, arterial stiffness and endothelial function are integrators of cardiovascular risk.

Non invasive explorations will be performed before randomization and after 4 to 5 weeks of insulin therapy, at fasting and each hour after a standardized breakfast.

It had three arms (groups): detemir (active comparator), aspart (active comparator) and detemir and aspart (active comparator).

Insulin detemir at dinner or bedtime.

Insulin aspart before each meal.

The registry classes the interventions as drug.

More on the Plan

Patients will be recruited in the department of Endocrinology-Diabetology-Nutrition of Jean VERDIER hospital, AP-HP, and the department of Endocrinology and Metabolism of AVICENNE hospital, BOBIGNY, AP-HP, France.

After an half day of cardiovascular explorations, 42 patients will be randomized in 3 groups determining their treatment for the following 4-5 weeks : insulin therapy with detemir at dinner or bed time, or with aspart at each meal, or with both of them.

Investigations will be performed in the morning 1) at the time of randomisation and 2) 4-5 weeks after the beginning of insulin therapy.

The researchers will evaluate at fasting and each hour after a standardized breakfast biological and metabolic parameters, arterial stiffness, endothelial function and nervous autonomic system with non-invasive devices: Sphygmocor®, Finapres®, laser-doppler et Endopat2000®.

Who Took Part

42 actual participants took part.

It was open to people of any sex aged from 30 years up to 72 years.

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

Examples of who could join: Adults from 30 to 72 years old. Type 2 diabetic patients for at least 1 year. Able to self measure capillary blood glucose. Body mass index 20-37 kg/m²,. Anti-hypertensive treatment or dyslipidemic treatment unchanged for 3 months.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: other antidiabetic medication in the previous 2 months,; anti-hypertensive or lipid-lowering therapies having been changed in the previous 2 months,; insulin allergy,.

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 2010-01 with completion listed for 2011-07.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Vago-sympathetic activity, arterial stiffness, endothelial function (time frame: 4-5 Weeks).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) and Insulin Detemir in 42 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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