The Effect of Liraglutide in Patients With Prediabetes and Kidney Failure

What Was Tested

This registered phase 2 trial tested Liraglutide.

The present study will examine the effects of liraglutide treatment during 26 weeks on several cardiovascular risk factors in patients with prediabetes and end-stage renal disease (ESRD).

Secondary objectives include various clinical and biochemical cardiovascular and safety parameters.

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

The registry classes the interventions as drug.

Who 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: End-stage renal disease treated with chronic maintenance dialysis (haemodialysis or peritoneal dialysis).

The full record lists 2 inclusion and 14 exclusion criteria; among the exclusions: diabetes mellitus type 1 or type 2 (diagnose according to who criteria); chronic pancreatitis / previous acute pancreatitis; known or suspected hypersensitivity to trial product(s) or related products.

How the Study Was Run

Design: randomized, parallel-group and triple-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, care provider and investigator.

It started in 2014-12 with completion listed for 2015-08.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Plasma glucose during oral glucose tolerance test at week 26 (time frame: The trial visit of week 26).

It also tracked 16 secondary outcomes, for example Hypoglycemic incidents, Fasting values of glucometabolic hormones, Insulin resistance, Beta cell function, Change in glycemic state and Blood pressure.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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