Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin

What Was Tested

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

This trial is conducted in Europe and North America.

It had three arms (groups): IDeg (non-randomised) (experimental), IDeg + IAsp (experimental) and IDeg + liraglutide (experimental).

The registry classes the interventions as drug.

Who Took Part

413 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: Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject). The subject must have completed the end of treatment visit of NN1250-3643 with Insulin degludec once daily + metformin. Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: participated in nn1250-3643 and treated with insulin glargine; previous treatment with glucacon like peptide (glp-1) receptor agonists (e.g. exenatide, liraglutide); impaired liver function, defined as alanine aminotransferase (alat) 2.5 times the upper limit of normal at end of treatment in nn1250-3643.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

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

It started in 2011-09 with completion listed for 2012-07.

It ran at 124 sites in United States (48), Canada (15), Germany (13), Norway (8), Spain (7) and Denmark (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin) (time frame: week 0, week 26).

It also tracked 3 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose (FPG), Change From Baseline in Body Weight and Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Aspart and Liraglutide in 413 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 and the Liraglutide compound page, all human trials.