Adding Liraglutide to High Dose Insulin: Breaking the Cycle

What Was Tested

The trial (phase 4) is built around Liraglutide.

Finally it will look at patient quality of life and safety.

It had two arms (groups): Liraglutide (active comparator) and Saline injection (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Type 2 diabetes is a progressive disease with incessant beta-cell dysfunction that often ultimately requires insulin treatment.

Who Took Part

The registry lists 71 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: Type 2 diabetes mellitus. Age ≥ 18. Stable comorbidities on stable treatment regimens. Ability to provide informed consent before any trial-related activities.

The full record lists 7 inclusion and 14 exclusion criteria; among the exclusions: type 1 diabetes mellitus; history of any pancreatic disease as it might interfere with the pancreatic tg measurement (i.e. pancreatitis, tumors, cysts, type 1 diabetes, any pancreatic surgery); incretin therapy (any glp-1 agonist or dpp-iv inhibitor).

How the Study Was Run

The set-up was 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.

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

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

It started in 2012-01 with completion listed for 2016-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Glycemic Control Measured by HbA1c (time frame: 6-months).

It also tracked 26 secondary outcomes, for example Pancreatic and Hepatic Triglyceride Content, Weight, Beta-Cell Function, Glucagon, Number of Daily Injections and Blood Pressure.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 71 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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