LANN-study: Lantus, Amaryl, Novorapid, Novomix Study

What Was Tested

The trial (phase 3) is built around Insulin Glargine and Insulin Aspart.

Many diabetics gain weight while on insulin therapy.

In this study, 150 diabetics whose diabetic control is inadequate while on maximal oral treatment will be randomized to either the new combination treatment or twice daily injections with a mixture of short- and longacting insulin or once-daily injection with a basal insulin analog.

The registry classes the interventions as drug.

More on the Plan

Diabetic patients failing on maximal oral treatment usually switch to twice daily administration of a mixture of short- and longacting insulin.

In this randomized controlled trial, 150 diabetics failing on maximal oral treatment will be randomized to preprandial use of Novorapid combined with Amaryl at 20.00 hours, twice daily Novomix 30, or once daily Lantus.

In the year after randomisation, patients will be followed for glycemic control, body weight, body composition, recorded number of hypoglycemic events, plasma lipid levels, basal and stimulated C-peptide levels and adverse effects.

Who Took Part

The registry lists 150 planned participants were the target.

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: BMI 25 - 35 kg/m2. Stable weight for at least three months (change maximal 2 kg).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

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

It started in 2005-05.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: glycemic control based on HbA1c. Body weight.

It also tracked 8 secondary outcomes, for example 8-point glucose day curve of three consecutive days, 24-hour glycemic control measured by continuous glucose monitoring for three consecutive days, recorded number of hypoglycemic events per month, waist circumference, dexa measurements of body composition and plasma lipid levels.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 150 people.

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

More context: the Insulin Glargine compound page and the Insulin Aspart compound page, all human trials.