Comparison of Insulin Detemir and Insulin Semilente®MC in Type 1 Diabetes

What Was Tested

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

This trial is conducted in Europe.

The registry classes the interventions as drug.

Who Took Part

71 actual participants took part.

It was open to people of any sex aged from 12 years up to 18 years.

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

Examples of who could join: Type 1 diabetes. Current intensified insulin treatment. Injection of insulin Semilente®MC at bedtime for at least 6 weeks. BMI maximum 32 kg/m\^2.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: current treatment with premixed insulin(s); impaired hepatic or renal function; recurrent major hypoglycaemia.

How the Study Was Run

Design: randomized, crossover and open-label.

The participants were allocated by chance, so the Insulin Detemir group and the comparison group should start out alike.

Each person switched between Insulin Detemir and the comparison at some point, usually with a gap in between.

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

It started in 2004-08-16 with completion listed for 2005-11-22.

It ran at 2 sites in Germany (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Fasting plasma glucose (time frame: after 16 and 32 weeks, respectively).

It also tracked 5 secondary outcomes, for example Adverse events, HbA1c results at the end of each treatment period, Blood glucose, Standard Laboratory Safety Parameters and Hypoglycaemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Detemir in 71 people.

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

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