Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Insulin Glargine and Insulin Aspart.

This trial is conducted in Asia, Europe and North America.

The aim of the trial is to compare FIAsp (faster-acting insulin aspart) to insulin aspart, both in combination with insulin glargine and metformin in adults with type 2 diabetes.

It had two arms (groups): Faster-acting insulin aspart (FIAsp) (experimental) and Insulin aspart (active comparator).

Meal time faster-acting insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication.

Meal time insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication.

The registry classes the interventions as drug.

Who Took Part

The registry lists 881 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, parallel-group and double-blind.

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

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 2013-09-09 with completion listed for 2015-01-22.

It ran at 144 sites in United States (77), Canada (13), Russia (12), India (10), United Kingdom (9) and Croatia (8).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in HbA1c (time frame: Week 0, Week 26).

It also tracked 3 secondary outcomes, for example Change From Baseline in 2-hour PPG Increment (Meal Test), Number of Treatment Emergent Confirmed Hypoglycaemic Episodes and Change From Baseline in Body Weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 881 people.

With 881 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.