Safety of Insulin Detemir Produced by a New Process as Measured by Antibody Formation in Subjects With Type 1 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Aspart and Insulin Detemir.

The trial was conducted in Germany, The Republic of Macedonia, Russian Federation, Serbia and South Africa.

The aim of this trial was to make a safety comparison of insulin detemir produced by a new production method (NN729) with insulin detemir made by the previous production method (NN304).

It had two arms (groups): NN304 (active comparator) and NN729 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 330 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Type 1 diabetes for at least 12 months. Basal-bolus treatment for at least 3 months. Body Mass Index (BMI) less than or equal to 35.0 kg/m\^2.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: known or suspected allergy to trial products or related products; pregnancy, breast-feeding or the intention to become pregnant or not using adequate contraceptive measures; receipt of any trial drug within 1 month prior to this trial.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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

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

Blinding on both sides kept the participants and researchers unaware of who received Insulin Aspart.

Those kept unaware of assignments: participant and investigator.

It started in 2007-03 with completion listed for 2008-07.

It ran at 5 sites in Germany (1), North Macedonia (1), Russia (1), Serbia and Montenegro (1) and South Africa (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Insulin Detemir - Human Insulin Cross-reacting Antibodies (time frame: week 0, week 52).

It also tracked 23 secondary outcomes, for example Hypoglycaemic Episodes, Glycaemic Control Parameters (Change in HbA1c), Glycaemic Control Parameters (Change in Fasting Plasma Glucose [FPG]), Glycaemic Control Parameters (9-point Self Measured Plasma Glucose [SMPG]), Change From Baseline in Detemir Specific Antibodies and Change From Baseline in Total Antibodies.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart and Insulin Detemir in 330 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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