Treatment of Latent Autoimmune Diabetes of the Adult

What Was Tested

This registered not phased trial tested NPH Insulin (isophane).

It had two arms (groups): Metformin + NPH Insulin (active comparator) and Metformin + sitagliptin +/-repaglinid (active comparator).

Patients are treated with metformin during the run-in period (3 months) and also after randomization. By randomization insulin treatment will be added in the form of injections of NPH insulin in the evenings.

The registry classes the interventions as drug.

More on the Plan

The aetiology and treatment of LADA patients is much less elucidated than is the case for type 1 diabetes (DM1) and type 2 diabetes (DM2).

LADA is therefore more common than insulin-requiring DM1.

LADA patients lose beta-cell function faster than patients with DM2.

Residual beta-cell function in DM1 is coupled to better metabolic control with lesser degree of hyperglycemia, lesser frequency of hypoglycaemic events and lesser diabetic complications.

Who Took Part

Enrollment: 64 actual participants took part.

It was open to people of any sex aged from 30 years up to 75 years.

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

Examples of who could join: Diabetes diagnosed during 0-3 years before entering the study. Age \> or equal to 30 years \< or equal to 75 years. Fasting C-peptide \> or equal to 0,3 ng/ml. No need for insulin treatment by clinical judgement for at least 3 months following the diagnosis of diabetes.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: renal insufficiency (plasma creatinine \> 150 mol/l); severe retinopathy (proliferative or pre-proliferative); severe cardiac disease (nyha iii-iv).

How the Study Was Run

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

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

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

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

It started in 2009-03 with completion listed for 2018-11.

It ran at 1 site in Norway.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): insulin secretion (time frame: 2 years).

It also tracked 1 secondary outcome, for example glycemic control.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of NPH Insulin (isophane) in 64 people.

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

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