Comparing Long-acting Insulins During Exercise in Type 1 Diabetes

What Was Tested

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

Exercise is an important part of a healthy lifestyle, and many people with Type 1 Diabetes like to take part in regular sport and exercise.

It had two arms (groups): Insulin detemir (active comparator) and Insulin glargine (active comparator).

Metabolism during and after submaximal exercise during treatment with insulin detemir.

Metabolism during and after submaximal exercise during treatment with insulin glargine.

The registry classes the interventions as drug.

More on the Plan

A1: At the first appointment, potential participants will be screened regarding the inclusion criteria, and if eligible to take part the study information sheet will be discussed with them in detail.

Written, informed consent will be obtained if participants are willing to take part in the study.

Participants will be given advice and support from this point in order to optimise basal insulin therapy using their usual basal insulin.

A2: Following a period of at least 3 weeks from recruitment into the study, participants will have their maximal oxygen uptake (VO2 MAX - a measure of capacity for physical exercise) assessed.

Who Took Part

Enrollment: 30 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Participant is willing and able to give informed consent for participation in the study. Male or Female, aged between 18 and 65 years. Diagnosed with Type 1 Diabetes Mellitus (T1DM). Treated with a basal bolus regimen using either insulin glargine or insulin detemir as the basal insulin. Exercising regularly for at least 1 hour per week on average.

How the Study Was Run

The set-up was non-randomized, crossover and open-label.

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

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

It started in 2011-11 with completion listed for 2012-06.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Glucose excursion (which, as defined below, is the change in blood glucose between the start and finish of one hour of exercise) (time frame: Between baseline and 1 hour).

It also tracked 13 secondary outcomes, for example Lactate, NEFA (Non-esterified fatty acids), B-OHB (beta-hydroxybutyrate), Catecholamines, Glucagon and Human growth hormone (hGH).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Insulin Glargine and Insulin Detemir in 30 people.

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

Its status is unknown; 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.