Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Aspart.

This trial is conducted in Asia, Europe, Oceania and South America.

The trial is conducted as a phase 4 trial in the majority of the participating countries.

It had three arms (groups): BIAsp 30 BID + sitagliptin + metformin (active comparator), BIAsp 30 BID + metformin (active comparator) and BIAsp 30 OD + sitagliptin + metformin (active comparator).

The registry classes the interventions as drug.

Who Took Part

582 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 6 months prior to screening (Visit 1). Subject is insulin-naïve (never previously treated with insulin). (However, short term insulin use due to intermittent illness of up to 14 days or insulin treatment for gestational diabetes is allowed). Body Mass Index (BMI) below or equal to 40.0 kg/m\^2. Able and willing to eat at least 2 meals (breakfast and dinner) every day during the trial.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: treatment with thiazolidinedione (tzd) or glucagon-like-peptide-1 (glp-1) receptor agonist within the last 3 months prior to screening (visit 1).

How the Study Was Run

Design: 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.

Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2012-06 with completion listed for 2013-10.

It ran at 69 sites in India (25), South Korea (8), Argentina (6), Greece (6), Portugal (6) and Brazil (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in HbA1c (Glycosylated Haemoglobin) (time frame: Week 0 to Week 24).

It also tracked 10 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose (FPG), Prandial Plasma Glucose (PPG) Increments at Breakfast, Prandial Plasma Glucose (PPG) Increments at Lunch, Prandial Plasma Glucose (PPG) Increments at Dinner, Prandial Plasma Glucose (PPG) Overall Mean Increment and Adverse Events (AEs).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 582 people.

With 582 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, all human trials.