Weight Gain, Eating Patterns, and Development of Body Composition During Initiation of Basal Insulin Therapy in Patients With Type 2 Diabetes: A Comparison of Insulin Detemir and Insulin Glargine

What Was Tested

This registered phase 3 trial tested Insulin Glargine and Insulin Detemir.

The main objective of this clinical trial is to investigate hepatic fat as the primary endpoint along with body fat, and weight changes after initiation of a basal insulin therapy together with data acquisition that is today's standard in studies investigating obesity and eating patterns with insulin detemir and insulin glargine.

It had two arms (groups): insulin Levemir (experimental) and insulin Lantus (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 66 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Age \> 18 years and \< 80 years. Gender: female, male. Type 2 diabetes. BMI: 20.0 - 38.0. Anti-GAD antibody negative.

The full record lists 8 inclusion and 19 exclusion criteria; among the exclusions: previous therapy with insulin within the last 3 months prior to inclusion into the study; previous therapy with glitazones within the last 6 months prior to inclusion into the study; change in therapy with lipid-lowering or anti-hypertensive agent within one month prior to inclusion into the study (a stable lipid-lowering or anti-hypertensive therapy is allowed).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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

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

It started in 2007-11.

It ran at 5 sites in Austria (3), Germany (1) and Switzerland (1).

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: To describe changes in hepatic fat content between groups (time frame: week 26, week 52).

It also tracked 9 secondary outcomes, for example To evaluate changes in body fat and visceral adipose tissue between groups, To describe changes in waist and hip circumferences between groups, To describe changes in eating behavior and food selection between groups, To describe changes in well being and disease perception between groups, To describe the fasting blood glucose between groups and To evaluate hypoglycaemia between groups.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Detemir in 66 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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