Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens

What Was Tested

The trial (phase 3) is built around Insulin Aspart.

This trial is conducted in Asia and North America.

It had two arms (groups): IDegAsp Simple (experimental) and IDegAsp Step wise (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 276 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: Type 2 diabetes (diagnosed clinically) for 24 weeks or longer prior to randomisation (visit 2). BMI (Body Mass Index) below or equal to 45 kg/m\^2. Ability and willingness to adhere to the protocol including self measurement of plasma glucose.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: treatment with glp-1 (glucagon like peptide) receptor agonists within the last 12 weeks prior to randomisation (visit 2); recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the investigator (trial physician); previous participation in this trial. participation is defined as randomised. re-screening is allowed once during the recruitment period.

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.

The Insulin Aspart group and the comparison group ran side by side rather than switching.

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

It started in 2011-06 with completion listed for 2012-04.

It ran at 42 sites in United States (25), South Korea (5), Turkey (Türkiye) (4), Malaysia (3), Mexico (2) and Thailand (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Glycosylated Haemoglobin (HbA1c) (time frame: Week 0, week 26).

It also tracked 4 secondary outcomes, for example Change in Fasting Plasma Glucose (FPG), Rate of Treatment Emergent Adverse Events (AEs), Rate of Confirmed Hypoglycaemic Episodes and Rate of Nocturnal Confirmed Hypoglycaemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 276 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.