A Study of Insulin Degludec/Insulin Aspart Biosimilar (22011) Compared With Insulin Degludec/Insulin Aspart(Ryzodeg) in Participants With Type 2 Diabetes in China

What Was Tested

This registered phase 3 trial tested Insulin Aspart.

The purpose of this study is to see if Insulin Degludec/Insulin Aspart (22011) compared to Insulin Degludec/Insulin Aspart (Ryzodeg) is similar in safety and effect in participants with type 2 diabetes (T2D).

It had two arms (groups): 22011 (experimental) and Ryzodeg (active comparator).

The registry classes the interventions as drug.

Who Took Part

414 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Informed consent obtained before any trial-related activities. Male or female, age at least 18 year-old and no more than 75 year-old at the time of signing informed consent. Type 2 diabetes mellitus (T2D). Body mass index (BMI) higher than 18.0, but below or equal to 35.0 kg/m\^2.

The full record lists 6 inclusion and 3 exclusion criteria; among the exclusions: have a diagnosis of type 1 diabetes (t1d), or specific type of diabetes other than t2d, for example, injured pancreas, diseases of acromegaly-induced diabetes; have a history of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening; have had severe hypoglycemia episodes within 6 months prior to screening.

How the Study Was Run

The set-up was 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.

Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.

It started in 2023-07-06 with completion listed for 2024-08-16.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline to Week 24).

It also tracked 9 secondary outcomes, for example Change From Baseline in Hemoglobin A1c (HbA1c) in Week 12, Change From Baseline in Fasting Plasma Glucose(FPG), Change From Baseline in Fasting Plasma Glucose(FPG) in Week24, Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values, Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values in Week24 and Change From Baseline in Body weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 414 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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