Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With T2DM

What Was Tested

In this not phased trial, researchers set out to test Insulin Aspart.

This trial will enable primary assessment of the clinically relevant endpoint of a change in HbA1c.

It had two arms (groups): IDegAsp group (experimental) and IDegAsp + IAsp group (active comparator).

IDegAsp twice daily.

IDegAsp once daily plus IAsp twice daily.

The registry classes the interventions as drug.

More on the Plan

The primary endpoint in this study is the change from baseline in HbA1c.

Patients with type 2 diabetes who meet the entry criteria are planned for inclusion in this trial.

Approximately 224 patients will be enrolled in the study.

Patients who qualify will be randomized to IDegAsp group or IDegAsp + IAsp group.

Who Took Part

Enrollment: 218 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: 1\. Informed consent has been obtained before any trial-related activities;. 2\. Patients aged 18\~75 years old (including 18 years old and 75 years old);. 3\. Clinical diagnosis of type 2 diabetes ≥ 6 months according to WHO diagnostic criteria before screening;. 4\. Use basal insulin once a day with or without other hypoglycemic drugs for at least 3 months before randomization;. 6\. Body mass index (BMI)≤40.0kg/m2;.

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: 1\. suffering from type 1 diabetes, or special type of diabetes;; 2\. known premixed insulin or idegasp used 3 month before randomization;; 4\. known or suspected subjects are allergic to test drugs, excipients or related similar products and excipients;.

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.

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 2023-03-23 with completion listed for 2025-08-15.

It ran at 7 sites in China (7).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: HbA1c (time frame: 16 weeks).

It also tracked 13 secondary outcomes, for example HbA1c response, Body weight, Fasted Blood Glucose, 7-Point Self-monitoring Blood Glucose, Continuous Glucose Monitoring and Percentage of Time In Range.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Aspart in 218 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.