A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Intensification

Plain-language guide to NCT02100475: phase 3 randomized trial of Insulin Aspart and Liraglutide, 31 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02100475
Phase: phase 3
Status: completed
Start: 2014-04
Completion (planned or actual): 2015-04
Participants: 31 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Diabetes; Diabetes Mellitus, Type 2
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Insulin Aspart and Liraglutide.

This trial is conducted globally.

This is an extension to trial NN9068-3952, NCT01952145 (DUAL™ V).

It had two arms (groups): Insulin degludec/liraglutide + Metformin (experimental) and Insulin degludec/liraglutide + Insulin Aspart + Metformin (active comparator).

The registry classes the interventions as drug.

Who Took Part

31 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: Completion (Visit 28) of NN9068-3952 with insulin degludec/liraglutide + metformin. HbA1c (glycosylated haemoglobin) above or equal to 7 percent at Visit 27 of NN9068-3952 trial.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: screening calcitonin above or equal to 50 ng/l.

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 2014-04 with completion listed for 2015-04.

It ran at 60 sites in Russia (11), Slovakia (9), United States (7), Spain (6), Argentina (5) and Australia (5).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 2 secondary outcomes, for example Change From Baseline in Body Weight and Number of Treatment-emergent Confirmed Hypoglycaemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart and Liraglutide in 31 people.

Its size is small, so on its own it can only give an early look.

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 and the Liraglutide compound page, all human trials.

Our Notes on the Compounds

Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.

Liraglutide: A once-daily GLP-1 receptor agonist peptide; sold as Victoza for type 2 diabetes and Saxenda for weight management.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.