Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Detemir.

This trial is conducted in Europe, and North and South America.

The aim of this trial is to investigate if a dietary intervention has an effect on weight when initiating insulin treatment in subjects with type 2 diabetes currently treated with oral antidiabetic drugs (OADs).

It had two arms (groups): Control (active comparator) and Dietician (experimental).

The registry classes the interventions as dietary supplement and drug.

Who Took Part

Enrollment: 611 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 2 diabetes (diagnosed clinically) for at least 6 months prior trial start. Insulin naive subjects. Body Mass Index (BMI): 25.0-45.0 kg/m\^2 (both inclusive).

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: use of thiazolidinedione (tzds) or glucagon-like peptide-1 analogue (glp- 1) receptor agonists within the last 3 months prior to trial enrollment; cardiovascular disease within the last 6 months; recurrent severe hypoglycaemia or hypoglycaemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months.

How the Study Was Run

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

Because people in this Insulin Detemir study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Being open-label, the Insulin Detemir study did not mask who received what.

It started in 2010-10-29 with completion listed for 2011-11-01.

It ran at 112 sites in United States (76), Germany (7), Argentina (5), Turkey (Türkiye) (5), Poland (4) and Russia (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Body Weight (time frame: Week 0, Week 26).

It also tracked 6 secondary outcomes, for example Change From Baseline in Body Mass Index (BMI), Change From Baseline in Glycosylated Haemoglobin (HbA1c), Change From Baseline in Fasting Plasma Glucose (FPG), Rate of Treatment Emergent Adverse Events (TEAEs), Rate of All Treatment Emergent Hypoglycaemic Episodes and Rate of Nocturnal Treatment Emergent Hypoglycaemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Detemir in 611 people.

With 611 participants it is a large trial for this field.

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, all human trials.