Early Insulin Treatment in Patients With Latent Autoimmune Diabetes

What Was Tested

This registered phase 4 trial tested Insulin (regular human).

These patients have a progressive beta cell destruction and most of them will be insulin dependent within 3-5 yrs.

It had two arms (groups): Insulin treatment (experimental) and Conventional treatment (no intervention).

Insulin given as soon as possible after diagnosis.

Diet, oral hypoglycemic agents and insulin first when clinically needed.

The registry classes the interventions as drug.

More on the Plan

All adult newly diagnosed diabetic patients in the certain areas are screened for pancreatic antibodies.

Patients clinically classified as Type 2, not insulin requiring at diagnosis and positive for at least one autoantibody are eligible for inclusion.

After randomisation to insulin treatment or diet and/or OHA, the patients are followed up with fasting C-peptide every third month.

A glucagon test is performed, and stimulated C-peptide and HbA1c, + clinical data and body weight are recorded at baseline and after 12, 24 and 36 months.

Who Took Part

42 actual participants took part.

It was open to people of any sex aged from 18 years up to 90 years.

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

Examples of who could join: Positive for pancreatic autoantibodies.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: \<18 yrs; not able to follow protocol.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

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

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 1995-02 with completion listed for 2002-04.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Glucagon stimulated C-peptide (time frame: 36 months after entering the study).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 42 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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