Insulin Effects on Metabolism and Cardiovascular Function in Type 2 Diabetes

What Was Tested

The trial (phase 4) is built around Insulin (regular human) and Insulin Aspart.

Compared to human insulins analogue insulins offer the option of optimizing metabolism also in type 2 diabetes.

It had two arms (groups): Hum (active comparator) and Ana (active comparator).

Use of human regular insulin and NPH insulin.

Use of insulin aspart and insulin detemir.

The registry classes the interventions as drug.

More on the Plan

This is a single centre, long term (24-48 months), therapy controlled and randomised study with blinded analysis of the ultrasound data in 120 patients with type 2 diabetes mellitus and with previous insulin therapy.

After recruitment and informed consent, patients are randomized to two treatment arms according to a randomisation protocol which takes into account age and absence or presence of cardiovascular events in each patient's history.

In one treatment arm, the intensive insulin therapy is based on human insulin (insulin NPH and regular human insulin) while in the other arm, the intensive insulin therapy is based on analogue insulin (insulin detemir and insulin aspart).

All patients will be updated in their skills of self medication by the departmental diabetic teaching programme und will receive life style instructions during each visit.

Who Took Part

120 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: Type 2 diabetes, insulin therapy.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: type 1 diabetes, bmi \>40, pregnancy,.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

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 (regular human) was given.

Those kept unaware of assignments: investigator.

It started in 2004-07 with completion listed for 2009-03.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: postprandial blood glucose at the end of the study and its change from baseline (time frame: 24-48 months treatment period).

It also tracked 1 secondary outcome, for example diastolic myocardial function.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Insulin Aspart in 120 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 Aspart compound page, all human trials.