Can Insulin Glargine Improve Myocardial Function in Patients With T2D and Coronary Artery Disease (CAD)

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine.

It had two arms (groups): insulin glargine (active comparator) and metformin (active comparator).

The registry classes the interventions as drug.

More on the Plan

After recruitment and informed consent, patients are randomized to two treatment arms which takes into account age and presence or absence of therapy with statins.

Who Took Part

Enrollment: 32 planned participants were the target.

It was open to people of any sex aged from 40 years up to 80 years.

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

Examples of who could join: Coronary artery disease. Type 2 diabetes of short duration including impaired glucose tolerance and impaired fasting glucose. Treatment by ≤1 OAD.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: contraindications for metformin or insulin glargine; on insulin therapy; pregnancy and breastfeeding.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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

Only one side, usually the participants, was kept unaware of whether Insulin Glargine was given.

Those kept unaware of assignments: investigator.

It started in 2005-04 with completion listed for 2010-02.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): change from baseline to endpoint in myocardial diastolic velocity E' (time frame: 24 weeks).

It also tracked 1 secondary outcome, for example glucose control.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 32 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.