Endothelial Effects of Basal Insulin: Detemir Versus Glargine

What Was Tested

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

Endothelial progenitor cell (EPC) level represents a surrogate marker of cardiovascular risk and an indicator of the ongoing vascular damage.

Moreover, EPCs are involved in the pathogenesis of virtually all diabetic complications.

Therefore, ways to modulate EPCs are currently considered of utmost importance, especially in high-risk subjects.

It had two arms (groups): Glargine (active comparator) and Detemir (experimental).

During this arm/phase patients take subcutaneous glargine daily for 3 months.

During this arm/phase, patients take insulin Detemir subcutaneously for 3 months.

The registry classes the interventions as drug.

More on the Plan

This is likely attributable to the widespread vascular damage due to uncontrolled hyperglycaemia and associated risk factors.

Endothelial dysfunction is universally recognised as the first step in the natural history of atherosclerosis.

High glucose concentration is one of the most detrimental factors that negatively affect endothelial cell function.

Through the classical damage pathways (including oxidative stress, PKC and MAP kinase activation and AGE accumulation), hyperglycaemia hampers the homeostasis of the vascular endothelial layer.

Who Took Part

50 planned participants were the target.

It was open to people of any sex aged from 35 years up to 80 years.

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

Examples of who could join: Type 2 diabetes. Macroangiopathy (coronary, or peripheral, or cerebrovascular). On oral antidiabetic therapy.

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: type 1 diabetes; acute diabetic decompensation; use of glitazones.

How the Study Was Run

Design: randomized, crossover and open-label.

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.

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.

It started in 2008-05 with completion listed for 2010-03.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in endothelial progenitor cell count (time frame: Basal, 3 months, 6 months).

It also tracked 3 secondary outcomes, for example Change in markers of endothelial damage, Frequence of hypoglycemias and Change in body weight.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Detemir in 50 people.

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 and the Insulin Detemir compound page, all human trials.