Addition of Liraglutide to Patients With Type 2 Diabetes Treated With Multiple Daily Insulin Injections

What Was Tested

The trial (phase 2) is built around Liraglutide.

However, to date there are no clinical trials of liraglutide added to insulin therapy, a population of patients generally having worse glycaemic control and weight gain.

In clinical guidelines, use of multiple daily insulin injections (MDI) is usually the final therapeutic option for type 2 diabetic patients.

It had two arms (groups): Liraglutide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Background Patients with type 2 diabetes are generally treated with metformin and diet as first-line therapy (1).

The next line of therapy includes adding basal or premixed insulin.

As a final step multiple daily insulin injections with basal and prandial insulin have become the standard if glycaemic control does not meet targets.

Obesity is another co-morbid condition in this population (3).

Who Took Part

The registry lists 124 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Informed consent obtained before trial-related activities (i.e., any activity that would not have been performed during routine patient management). Type 2 diabetes. Adult patients over 18 years of age and less than or equal to 80 years of age. Treated with MDI for at least the last 6 months. Treated with/without metformin as only diabetes therapy apart from insulin.

The full record lists 8 inclusion and 22 exclusion criteria; among the exclusions: type 1 diabetes; unstable cardiovascular disease, nyha class ii or greater heart failure , new symptoms of cardiovascular disease); acute coronary syndrome, stroke, coronary artery intervention or myocardial infarction during the previous 6 months.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2013-01 with completion listed for 2014-08.

It ran at 14 sites in Sweden (14).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c from baseline to week 24 (time frame: Baseline, week 24).

It also tracked 18 secondary outcomes, for example Change in weight from baseline to week 24, Change in fasting glucose from baseline to week 24, Change in the standard deviation of CGM from the run-in period to week 23-24, Change in mean glucose levels on CGM from the run-in period to week 23-24, Change in 1.5 hour postprandial glucose levels on capillary glucose measurements from the run-in period to week 23-24 and Change in the score of the DTSQs from baseline to week 24.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 124 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.