Liraglutide Treatment to Patients With Severe Renal Insufficiency

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide.

Incretin-based therapy for the treatment of patients with type 2 diabetes mellitus (T2D) is new and fundamentally different from the classical treatments with oral antidiabetic agents and insulin.

At present there is virtually no knowledge of the physiology and clinical implications of the role of incretin hormones and incretin-based therapy in this group of diabetic patients.The aim of the study is to establish an evidence-based rationale for introducing a GLP-1 analogue to the limited armamentarium of antidiabetic drugs for patients with type T2D and severe renal insufficiency.

It had four arms (groups): T2D, Dialysis, Liraglutide (active comparator), T2D, Dialysis, Placebo (placebo comparator), T2D, Normal kidney function, Liraglutide (active comparator) and T2D, Normal kidney function, Placebo (placebo comparator).

Daily liraglutide treatment Chronic dialysis treatment.

Daily placebo Chronic dialysis treatment.

Daily Liraglutide treatment Normal kidney function.

The registry classes the interventions as drug.

Who Took Part

40 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Male or female; aged 18-85 years. End-stage renal disease. Chronic dialysis treatment (minimum 3 months). T2D (diagnosed according to WHO criteria). Treated with diet/lifestyle intervention, oral antidiabetic drugs (SU, glitazones) and/or insulin.

The full record lists 12 inclusion and 16 exclusion criteria; among the exclusions: both groups; type 1 diabetes mellitus; chronic pancreatitis / previous acute pancreatitis.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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

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 and investigator.

It started in 2011-09 with completion listed for 2013-10.

It ran at 3 sites in Denmark (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Plasma liraglutide concentration (pmol/L) (time frame: 12 weeks).

It also tracked 4 secondary outcomes, for example Hypoglycaemia; minor or major, Glycaemic control, Pancreatic beta-cell function and Cardiovascular risk factors (lipids and blood pressure).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 40 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.