Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes

What Was Tested

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

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

It had two arms (groups): FIAsp and basal insulin + metformin (experimental) and Basal insulin + metformin (active comparator).

Subjects will receive FIAsp combined with their pre-trial basal insulin (insulin human, insulin detemir or insulin glargine) treatment in combination with their pre-trial metformin.

Subjects will continue their pre-trial basal insulin (insulin human, insulin detemir or insulin glargine) treatment in combination with their pre-trial metformin.

The registry classes the interventions as drug.

Who Took Part

The registry lists 323 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.

Examples of who could join: Type 2 diabetes (diagnosed clinically) for at least 6 months prior to the screening visit (Visit 1). Current treatment with once daily insulin detemir, insulin glargine or human isophane insulin, NPH for at least 3 months prior to the screening visit (Visit 1). Body mass index (BMI) equal or less than 40.0 kg/m\^2.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: use of glucagon-like peptide-1 (glp-1) agonists and/or thiazolidinediones (tzd) within the last 3 months prior to screening (visit 1).

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

The Insulin Aspart group and the comparison group ran side by side rather than switching.

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

It started in 2013-09-23 with completion listed for 2014-11-17.

It ran at 58 sites in United States (32), India (9), Argentina (5), Romania (5), Slovenia (4) and Mexico (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in HbA1c (time frame: Week 0, week 18).

It also tracked 5 secondary outcomes, for example Change From Baseline in Body Weight, Number of Treatment Emergent Hypoglycaemic Episodes and Number of Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 323 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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