A Phase III Study of Insulin Aspart Injection to Evaluate the Efficacy and Safety

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Aspart.

This is a multicenter, randomized, open, parallel group, active-controlled study.

The study period is 25 to 26 weeks, including screening period of 1-2 weeks and treatment period of 24 weeks.

It had two arms (groups): insulin Aspart injection (experimental) and insulin Aspart injection (NovoRapid) (active comparator).

Subcutaneous injection of insulin Aspart prior to three meals every day, while subcutaneous injection of Lantus at bedtime.

Subcutaneous injection of insulin Aspart (NovoRapid) prior to three meals every day, while subcutaneous injection of Lantus at bedtime.

The registry classes the interventions as biological.

More on the Plan

After the screening visit, all patients who met all inclusion criteria and do not meet any of the exclusion criteria were randomized into the experimental group or the controlled group.

The subjects in the experimental arm will receive insulin aspart injection combined with basal insulin (Lantus ®), and the subjects in the controlled arm will receive NovoRapid ® (active control) combined with basal insulin (Lantus ®).

The experimental drug or the controlled drug will be administered subcutaneously prior to three meals (or can be administered immediately after meal if necessary), and the basal insulin (Lantus ®) will be administered at bedtime.

The treatment period is 24 weeks, during which the subjects will be followed up at the clincic cetres at 1, 2, 4, 8, 12, 18, 24 weeks of treatment.

Who Took Part

563 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: Patients were diagnosed with diabetes；. Insulin therapy for at least 3 months before recruitment；.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: patients to study drug allergy；; to liver and kidney impairment；; liver and kidney impairment；.

How the Study Was Run

Design: 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.

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

It started in 2015-06-19 with completion listed for 2016-08-12.

It ran at 2 sites in China (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The change of relative baseline HbA1c (time frame: 24 weeks).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 563 people.

With 563 participants it is a large trial for this field.

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.