Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes

What Was Tested

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

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

This trial consists of two periods: a 26 week treatment period followed by a 26 week additional treatment period.

It had three arms (groups): Meal time FIAsp and insulin detemir (experimental), Meal time insulin aspart and insulin detemir (active comparator) and Post meal FIAsp and insulin detemir (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1290 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

It was run as a randomized, parallel-group and double-blind study.

Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Blinding on both sides kept the participants and researchers unaware of who received Insulin Aspart.

Those kept unaware of assignments: participant and investigator.

It started in 2013-08-26 with completion listed for 2015-05-12.

It ran at 191 sites in United States (116), Germany (25), Canada (12), United Kingdom (10), Finland (6) and Hungary (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in HbA1c (Glycosylated Haemoglobin) (time frame: Week 0, week 26).

It also tracked 7 secondary outcomes, for example Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test), Change From Baseline in HbA1c (Post Meal Arm), Number of Treatment Emergent Confirmed Hypoglycaemic Episodes, Change From Baseline in Body Weight, Frequency of Adverse Events and Change in HbA1c.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart and Insulin Detemir in 1290 people.

With 1290 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 Aspart compound page and the Insulin Detemir compound page, all human trials.