Basal Analog Study - Comparison of Lantus or Levemir With NPH Insulin From T1DM Diagnosis

What Was Tested

The trial (phase 4) is built around Insulin Glargine and Insulin Detemir.

This a randomized, open-label, parallel-group trial of 120 children, 7 - 17 years of age, newly diagnosed with T1DM.

It had three arms (groups): Insulatard (active comparator), Lantus (active comparator) and Levemir (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 120 actual participants took part.

It was open to people of any sex aged from 7 years up to 17 years.

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

Examples of who could join: Diagnosis of diabetes and novel to insulin therapy. Age 7 - 17 years.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: suspected non-type 1; IA2 and GAD65: all-antibody negative; celiac disease or other chronic disease.

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 Glargine and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2005-09 with completion listed for 2011-03.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: HbA1c (time frame: 1 year).

It also tracked 2 secondary outcomes, for example Stimulated C-peptide and IGF-I.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Detemir in 120 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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