A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine and Insulin Aspart.

This trial is conducted in Europe and the United States of America (USA).

It had two arms (groups): IDeg OD + IAsp followed by IGlar OD + IAsp (experimental) and IGlar OD + IAsp followed by IDeg OD + IAsp (active comparator).

Each treatment period consists of a 16-week wash-out period and a 16-week maintenance period.

Each treatment period consists of a 16-week wash-out period and a 16-week maintenance period.

The registry classes the interventions as drug.

Who Took Part

The registry lists 501 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.

The full record lists 0 inclusion and 1 exclusion criteria.

How the Study Was Run

Design: randomized, crossover and double-blind.

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.

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2014-01-05 with completion listed for 2016-01-11.

It ran at 99 sites in United States (92), Poland (6) and Puerto Rico (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Treatment Emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period (time frame: A 16-week treatment period).

It also tracked 5 secondary outcomes, for example Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episodes During the Maintenance Period, Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period, Incidence of Treatment Emergent Adverse Events, Change From Baseline in HbA1c (Glycosylated Haemoglobin) and FPG (Fasting Plasma Glucose).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 501 people.

With 501 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 Glargine compound page and the Insulin Aspart compound page, all human trials.