Effect of Insulin Detemir on Use of Energy in Type 1 Diabetes

What Was Tested

This registered phase 4 trial tested Insulin Aspart and Insulin Detemir.

This trial is conducted in Europe.

The purpose of this trial is to investigate if there is any change in the mechanism of energy expenditure (i.e. the way in which energy is used) in patients with type 1 diabetes, whilst taking two different, commercially available insulins for the treatment of their diabetes.

It had two arms (groups): Treatment period 1 (experimental) and Treatment period 2 (experimental).

Insulin detemir for 16 weeks (treatment period 1) followed by insulin NPH treatment for 16 weeks (treatment period 2) in addition to meal-time insulin aspart.

Insulin NPH for 16 weeks (treatment period 1) followed by insulin detemir treatment for 16 weeks (treatment period 2) in addition to meal-time insulin aspart.

The registry classes the interventions as drug.

More on the Plan

The study had been temporarily halted due to an unplanned interim analysis.

Who Took Part

Enrollment: 23 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 more than 12 months. Current treatment: Basal-bolus insulin regimen for more than three months (i.e. at least one daily injection of long-acting insulin (including insulin glargine) and fast-acting insulin with each main meal). Able and willing to maintain consistent physical activity level throughout the entire study period. Able and willing to maintain consistent eating habits throughout the entire study period.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: proliferative retinopathy that has required acute treatment within the last six months; recurrent major hypoglycaemia or hypoglycaemic unawareness as judged by the investigator; liver, kidney or heart problems as judged by the investigator.

How the Study Was Run

Design: randomized, crossover and open-label.

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

In the crossover set-up each of the participants took both Insulin Aspart and the comparison in turn, acting as their own control.

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

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

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Total Energy Expenditure, Double-labelled Water Method (time frame: Weeks 14-16, weeks 30-32). Total Energy Expenditure, Dietary Record Method (time frame: Weeks 14-16, weeks 30-32).

It also tracked 16 secondary outcomes, for example Component of Total Energy Expenditure: Resting Energy Expenditure (REE), Component of Total Energy Expenditure: Diet Induced Thermogenesis (DIT), Component of Total Energy Expenditure: Physical Activity Thermogenesis, Component of Total Energy Expenditure: Non-exercise Activity Thermogenesis (NEAT), Body Weight and Lean Body Mass.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart and Insulin Detemir in 23 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); 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.