Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With T1DM

What Was Tested

The trial (not phased) is built around Insulin Aspart.

This trial will enable assessment of the clinically relevant endpoint of a change in HbA1c and Time in Range (TIR).

It had two arms (groups): IDegAsp group (experimental) and basal insulin plus pre-prandial insulin group (active comparator).

IDegAsp twice daily.

Basal insulin once or twice daily plus pre-prandial insulin.

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 1 diabetes who meet the entry criteria are planned for inclusion in this trial.

Approximately 40 patients will be enrolled in the study.

Patients who qualify will be randomized to IDegAsp group or basal plus pre-prandial insulin group.

Who Took Part

40 planned participants were the target.

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: Patients ≥ 18 and ≤75 years with type 1 diabetes;. Diagnosed as T1DM ≥ 12 months before enrollment in the study;. Receipt of basal plus pre-prandial insulin and/or oral anti-diabetic agents ≥ 12 weeks before enrollment in the study;. BMI ≤ 35kg / m2.

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: patients with any of the following conditions will be excluded:; pregnant or lactating women; severe hypoglycemia within one month;.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin Aspart and who got the comparison, which limits bias.

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 2021-08 with completion listed for 2023-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 6 secondary outcomes, for example Time In Range (TIR), Time to occurrence of treat to target, Occurrence of a treat to target response and without any hypoglycemic episodes, EQ-5D Health Questionnaire and Short Form 36 (SF-36).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Aspart in 40 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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