A Trial Comparing the Effect of Exercise on Blood Glucose in Subjects With Type 1 Diabetes, Who Are Treated With Either Insulin Degludec or Insulin Glargine

What Was Tested

This registered phase 1 trial tested Insulin Glargine.

This trial is conducted in Europe.

The aim of the trial is to compare the effect of exercise on blood glucose in subjects with type 1 diabetes, who are treated with either insulin degludec (IDeg) or insulin glargine (IGlar).

It had two arms (groups): IDeg followed by IGlar (experimental) and IGlar followed by IDeg (experimental).

The registry classes the interventions as drug.

Who Took Part

40 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months. Body mass index 18.0-27.0 kg/m\^2 (both inclusive). Subjects performing regular physical cardiorespiratory activity.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day); not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period; supine blood pressure at screening (after resting for at least 5 minutes) outside the range of 90-140 mmhg for systolic or 50-90 mmhg for diastolic.

How the Study Was Run

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

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

Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.

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

It started in 2012-10 with completion listed for 2013-03.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): BGpre-exe - BGminimum,exe, difference between blood glucose concentration before exercise and the minimum blood glucose concentration observed during exercise (time frame: From 0 to 30 minutes).

It also tracked 3 secondary outcomes, for example BGmean,exe, mean blood glucose concentration during exercise, BGmean,30-180min,post-exe, mean blood glucose concentration and BGminimum,30-180min,post-exe, minimum blood glucose concentration.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 40 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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