A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

What Was Tested

This registered phase 3 trial tested Insulin Aspart.

This trial is conducted in Africa, Europe and the United States of America (USA).

The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.

It had two arms (groups): IDegAsp BID+/-OADs (experimental) and IDeg OD plus IAsp +/-OADs (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 274 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: Diagnosis of type 2 Diabetes Mellitus at the discretion of the investigator for at least 26 weeks prior to screening (visit 1). Treatment with basal insulin for at least 12 weeks prior to randomisation with or without metformin, sulphonylurea (SU)/glinide, DPP-4 inhibitors, alfa-glucosidase-inhibitors. Body mass index (BMI) less than or equal to 40.0 kg/m\^2.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: treatment with glucose-lowering agent(s) other than those stated in the inclusion criteria; stroke; heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; chronic disorder or disease which might jeopardise safety or compliance.

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.

Being open-label, the Insulin Aspart study did not mask who received what.

It started in 2013-02-21 with completion listed for 2014-01-09.

It ran at 51 sites in United States (26), France (8), Austria (7), Norway (6) and Algeria (4).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 5 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose (FPG), Number of Treatment Emergent Hypoglycaemic Episodes, Number of Treatment Emergent Hypoglycaemic Episodes, Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes and Incidence of Treatment Emergent Adverse Events (TEAE).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart in 274 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.