Prevention of Clinical Onset of Type 1 Diabetes in High Risk First Degree Relatives

What Was Tested

In this phase 2 trial, researchers set out to test Insulin (regular human).

It had two arms (groups): 1 (active comparator) and 2 (no intervention).

56 subjects will receive metabolically active insulin by subcutaneous injections for 36 months (twice daily).

The registry classes the interventions as drug.

More on the Plan

Endpoints: Fasting glycemia; fasting and stimulated plasma C-peptide and proinsulin values; islet cell autoantibodies; incidence of hypoglycemia; body weight gain.

Who Took Part

The registry lists 112 actual participants took part.

It was open to people of any sex aged from 5 years up to 39 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Sibling/offspring of a Type 1 diabetic patient. In good general condition. Age 5-39 years. Impaired Fasting Glucose (IFG):. Impaired Glucose Tolerance (IGT):.

The full record lists 16 inclusion and 12 exclusion criteria; among the exclusions: diabetes by 1997 ada criteria (33):; donation of blood during the study or within one month prior to screening; pregnancy or lactation in women.

How the Study Was Run

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

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

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2000-02 with completion listed for 2004-04.

It ran at 3 sites in Belgium (3).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Fasting glycemia; (time frame: 2004). fasting and stimulated plasma C-peptide and proinsulin values; (time frame: 2004). islet cell autoantibodies; (time frame: 2004).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Insulin (regular human) in 112 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.