Insulin Treatment in Diabetic Older People With Heart Failure.

What Was Tested

The trial (phase 2) is built around Insulin (regular human).

It had two arms (groups): non insulin (no intervention) and Insulin (experimental).

Standard care + antidiabetic therapy non insulin.

Standard care including insulin.

The registry classes the interventions as drug.

More on the Plan

The project will consist in a controlled, randomized, open-label (PROBE design) multicenter, pilot study.

Central randomization stratified by center, performed online, will allow a comparison of two groups of patients one receiving standard care including insulin, the other standard care without insulin.

Patients considered not eligible for randomization will be included in a registry.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to people of any sex aged from 70 years up to 100 years.

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

Examples of who could join: Men and women aged ≥70 years;. At discharge after admission to hospital for worsening of HF or ambulatory patients with chronic HF;. New York Heart Association (NYHA) class II or III. With any level of left ventricular ejection fraction;. Plasma natriuretic peptide (BNP) ≥200 pg/mL or N-terminal pro-BNP ≥900 pg/mL (NT pro-BNP).

The full record lists 8 inclusion and 8 exclusion criteria; among the exclusions: unstable diabetes: type of diabetes presentation in patients with an anamnesis of frequent episodes of hypoglycemia, hyperglycemic hyperosmolar state, ketoacidosis or lactic acidosis;; planned cv surgery or angioplasty in 3 months;; any non-cardiac disease that shortens life expectancy to\<1 year (e.g.most cancers);.

How the Study Was Run

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

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

In this single-blind Insulin (regular human) study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2018-11-08 with completion listed for 2019-09-18.

It ran at 3 sites in Italy (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in blood glucose variability (time frame: baseline to 12 months).

It also tracked 13 secondary outcomes, for example Number of patients with episodes of hypoglycemia, Change in body weight, Change in plasma concentration of a natriuretic peptide, Changes in urinary albumin excretion, Change in New York Heart Association (NYHA) class and All-cause hospitalizations.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 10 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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