Insulin Detemir Compared to Insulin Glargine: Appetite and Calories Consumed in Type 1 Diabetes

What Was Tested

This registered not phased trial tested Insulin Glargine and Insulin Detemir.

Patients with diabetes treated with insulin often gain weight, which may deter patients from adhering to insulin treatment.

Detemir is one type of long acting insulin approved by the Food and Drug Administration for use in people with diabetes.

It had two arms (groups): Insulin Detemir (experimental) and Insulin Glargine (experimental).

Insulin Detemir.

Insulin Glargine.

The registry classes the interventions as drug.

More on the Plan

Insulin detemir is a neutral, soluble long acting insulin analog with weight neutral properties.

The primary objective of this study is to determine if patients with type 1 diabetes consume fewer calories when allowed to eat to satiety while treated with insulin detemir compared to insulin glargine.

Secondary objectives are 1) subject responses on validated satiety scales and food diaries, 2) bioelectrical impedance analysis, 3) resting energy expenditure on indirect calorimetry/metabolic cart measurement, and 4) centrally acting mediators of satiety measured in the serum (Peptide YY \[PYY\], ghrelin, leptin).

Who Took Part

10 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Type 1 diabetes. Treated with long-acting and meal time insulin therapy for at least 2 years. Ages 18 to 60 years of age.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: severe medical illness or medical conditions including congestive heart failure, angina, liver failure or renal failure; alcohol or drug abuse or dependence within three months of study entry; women of child-bearing age not adhering to the following contraceptive methods: oral contraceptives, barrier methods including condoms or diaphragm, or abstinence.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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

Neither the participants nor the staff measuring them knew who was on Insulin Glargine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2008-04 with completion listed for 2010-12.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Calories Consumed After Fast (time frame: Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Glargine and Insulin Detemir in 10 people.

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

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

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