Prospective Influence of Bedtime Insulin Glargine on Mobilization and Function of Endothelial Progenitor Cells

What Was Tested

In this phase 4 trial, researchers set out to test Insulin (regular human) and Insulin Glargine.

This will be done using laser Doppler measurements of the skin; in addition, MRI of the heart will be performed which is capable of quantifying the perfusion reserve of the myocardium and additional functional aspects of ventricular function.

It had three arms (groups): 1 (no intervention), 2 (experimental) and 3 (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 75 planned participants were the target.

It was open to people of any sex aged from 35 years up to 70 years.

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

Examples of who could join: Type 2 Diabetes. Oral antidiabetic therapy. Age 35 - 70. Ability of subject to understand character and individual consequences of clinical trial. Written informed consent must be available before enrollment in the trial.

The full record lists 11 inclusion and 17 exclusion criteria; among the exclusions: malignant disease; hematopoietic disorders; autoimmune disease.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2007-08 with completion listed for 2009-12.

It ran at 1 site in Germany.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Change of number of circulating EPC 4 weeks after start of therapy compared to baseline as detected by FACS analysis (time frame: 4 weaks of treatment).

It also tracked 7 secondary outcomes, for example Change of number of circulating EPC 4 as detected by in vitro outgrowth, Skin microvascular function (as measured by laser Doppler perfusion upon heat stimulation), Myocardial function and myocardial perfusion reserve as measured by MRI, Intima-Media-Thickness, Long-term Glucose control (HbA1c) and Short-term Glucose control (fasting glucose).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Insulin Glargine in 75 people.

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 Glargine compound page, all human trials.