Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Detemir and NPH Insulin (isophane).

This trial is conducted in Europe.

The aim of this clinical trial is to compare the change in trunk fat mass, assessed by Double Energy X-ray Absorptiometry (DEXA) after 26 weeks of treatment with insulin detemir or insulin NPH (Neutral Protamine Hagedorn) (both combined with insulin aspart at the main meals) in overweight and obese subjects with type 2 diabetes.

It had two arms (groups): insulin detemir (experimental) and insulin NPH (active comparator).

Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks.

Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 60 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: Body Mass Index (BMI) between 27.5-40 kg/m\^2.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: previous or planned surgical treatment of obesity; proliferative retinopathy or maculopathy that has required acute treatment within the last six months; receipt of any investigational drug within 1 month prior to this trial.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

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

It started in 2009-04 with completion listed for 2010-08.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio) (time frame: week 0, week 26). Absolute Change in Trunk Fat Mass (time frame: week 0, week 26).

It also tracked 54 secondary outcomes, for example Absolute Change in Whole Body Fat Mass, Percentage Change in Whole Body Fat Mass, Absolute Change in Whole Body Lean Mass, Percentage Change in Whole Body Lean Mass, Absolute Change in Trunk Lean Mass and Percentage Change in Trunk Lean Mass.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Detemir and NPH Insulin (isophane) in 60 people.

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

More context: the Insulin Detemir compound page and the NPH Insulin (isophane) compound page, all human trials.