Intervention to Preserve Beta-Cell Function in GAD Ab-Positive Diabetes

What Was Tested

This registered not phased trial tested Insulin (regular human).

The researchers tested the hypothesis that insulin therapy rather than sulfonylurea (SU) treatment has a preferable outcome to reverse or preserve beta cell function in the patients with diabetes that is called slowly progressive insulin-dependent (type 1) diabetes (SPIDDM) or latent autoimmune diabetes in adult (LADA).

The registry classes the interventions as drug.

More on the Plan

Serum C-peptide response to annual oral glucose tolerance tests were followed for 57 mean months.

The primary endpoint was insulin-dependency (IDDM: integrated C-peptide values \[sigma C-peptide\] \<4 ng/ml).

Who Took Part

42 planned participants were the target.

It was open to people of any sex.

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

Examples of who could join: Subjects should use SU agents to obtain as a goal good glycemic control. Duration of diabetes within 5 years from the onset (or diagnosis).

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: subjects having history of hyperglycemia requiring insulin treatment and/or history of ketosis/ketoacidosis were excluded; subjects with malignant diseases, systemic inflammatory diseases, renal or liver disorders or malabsorption were also excluded.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 1996-01 with completion listed for 2005-01.

It ran at 1 site in Japan.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: The primary endpoint was insulin-dependency (IDDM: integrated C-peptide values [sigma C-peptide] <4 ng/ml).

What This Means in Plain Language

Put simply, this is a not phased, 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.