Comparing Efficacy and Safety of Thrice Daily Versus Twice Daily NovoMix® 30 (Biphasic Insulin Aspart 30) in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin

What Was Tested

This registered phase 4 trial tested Insulin Aspart.

This trial is conducted in Asia.

It had two arms (groups): BIAsp 30 TID (experimental) and BIAsp 30 BID (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 437 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: Male or female, age at least 18 years at the time of signing informed consent. For Algeria only: age at least 19 years at the time of signing informed consent. Type 2 diabetes subjects clinically diagnosed for at least 12 months prior to the day of screening (Visit 1). Able and willing to intake three main meals daily (breakfast, lunch and main evening meal) throughout the trial. Definition of main meal as judged by the investigator.

The full record lists 6 inclusion and 3 exclusion criteria; among the exclusions: impaired liver function, defined as alanine aminotransferase (alt) equal to or above 2.5 times upper normal limit at screening (visit 1).

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

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 2015-10-19 with completion listed for 2017-03-18.

It ran at 50 sites in China (25), India (8), Turkey (Türkiye) (5), Taiwan (4), Ukraine (4) and Algeria (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Glycosylated Haemoglobin (HbA1c) (time frame: Week 0, Week 24).

It also tracked 17 secondary outcomes, for example Number of Treatment Emergent Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition, Change From Baseline in FPG by Central Laboratory Analysis, 7-point SMPG Profile, 7-point SMPG Profiles: Change From Baseline in 2-hour PPG at Individual Meal (Breakfast, Lunch and Main Evening Meal), 7-point SMPG Profiles: Change From Baseline in PPG Increment at Individual Meal (Breakfast, Lunch and Main Evening Meal) and 7-point SMPG Profiles: Change From Baseline in Mean of 2-hour PPG Over 3 Main Meals (Breakfast, Lunch and Main Evening Meal).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 437 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.