Comparison of Biphasic Insulin Aspart 30 Individually Adjusted by the Subject and the Trial Physician, Both Combined With Metformin in Subjects With Type 2 Diabetes

What Was Tested

This registered phase 4 trial tested Insulin Aspart.

This trial was conducted in Asia, Europe and South America.

It had two arms (groups): Subject-driven titration BIAsp 30 (BID) + metformin (experimental) and Investigator-driven titration BIAsp 30 (BID) + metformin (active comparator).

The registry classes the interventions as drug.

Who Took Part

348 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: Diagnosed with type 2 diabetes for a minimum of 12 months prior to Visit 1 (screening). Currently treated with a basal insulin analogue for at least 3 months prior to Visit 1 (screening). Body Mass Index (BMI) below or equal to 40.0 kg/m\^2. Able and willing to eat at least 2 main meals each day during the trial. Able and willing to adhere to the protocol including compliance with performance of self measured plasma glucose (SMPG), injection regimen and titrating themselves according to the protocol.

The full record lists 8 inclusion and 5 exclusion criteria; among the exclusions: treatment with any thiazolidinedione (tzd) and glucagon-like peptide-1 (glp-1) receptor agonists or pramlintide within the last 3 months prior to visit 1 (screening).

How the Study Was Run

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

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

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

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

It started in 2011-09 with completion listed for 2012-07.

It ran at 41 sites in India (8), Poland (8), Spain (7), United Kingdom (7), China (6) and Argentina (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c (Glycosylated Haemoglobin) - FAS (time frame: Week 0, week 20). Change in HbA1c (Glycosylated Haemoglobin) - PP (time frame: Week 0, week 20).

It also tracked 5 secondary outcomes, for example Change in Fasting Plasma Glucose (FPG) (Central Laboratory Values), Number of Treatment Emergent Hypoglycaemic Episodes, Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score, Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score and Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 348 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.