A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events

What Was Tested

The trial (phase 3) is built around Insulin Glargine.

This trial is conducted globally.

The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.

It had two arms (groups): Insulin degludec (IDeg) (experimental) and Insulin glargine (IGlar) (active comparator).

All subjects will continue their current antidiabetic therapy except for the basal insulin component (if any) that will be replaced by the investigational product.

All subjects will continue their current antidiabetic therapy except for the basal insulin component (if any) that will be replaced by the investigational product.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 7637 actual participants took part.

It was open to people of any sex aged from 50 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

The set-up was randomized, parallel-group and double-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2013-10-29 with completion listed for 2016-10-16.

It ran at 446 sites in United States (267), India (30), Russia (22), South Africa (15), Italy (14) and Brazil (11).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example Number of EAC-confirmed Severe Hypoglycaemic Episodes, Occurrence of at Least One EAC Confirmed Severe Hypoglycaemic Episode Within a Subject (Yes/no) and Change in Glycosylated Haemoglobin (HbA1c).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 7637 people.

With 7637 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, all human trials.