Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting

What Was Tested

This registered phase 2 trial tested Liraglutide.

Hypothesis: In type 1 diabetes mellitus, in the setting of a closed loop glucose control system: adjunctive therapy with Liraglutide will afford better post-prandial glycemic excursions than insulin mono-therapy.

Specific Aim: To determine if post-prandial glucose excursions are lowered with the addition of Liraglutide compared to insulin mono-therapy.

Study Design: This is a randomized open labeled crossover design trial comparing adjuvant Liraglutide and insulin Vs. insulin mono-therapy using the ePID closed-loop system for insulin delivery.

It had two arms (groups): Closed loop with sensor and Insulin (placebo comparator) and Closed loop with sensor, Insulin and Liraglutide (active comparator).

Subject will be on the closed loop device with enlite sensors for about 27 hours. They will not be on any study medication and will be on insulin alone.

The registry classes the interventions as drug.

More on the Plan

After the screening visit, subjects will be randomized to come for two overnight visits.

Study A- the subjects will be on the closed loop device with Novolog rapid acting insulin.

Both visits will last for approximately 30 hours and the subjects will be managed by the closed loop device for approximately 25 hours.

Who Took Part

18 actual participants took part.

It was open to people of any sex aged from 18 years up to 40 years.

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

Examples of who could join: Age greater than 18 years and less than 40 years. Be on continuous subcutaneous insulin infusion using an insulin pump. Menstruating women must have negative pregnancy test. Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 3 months prior to Screening:. Should not have any alcohol or drug dependency as assessed by CRAFFT questionnaire.

The full record lists 8 inclusion and 15 exclusion criteria; among the exclusions: positive pregnancy test in menstruating young women; evidence or history of chemical abuse; weight less than 50 kg.

How the Study Was Run

Design: randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

Each person switched between Liraglutide and the comparison at some point, usually with a gap in between.

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2013-01 with completion listed for 2015-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone (time frame: 0-1500 min).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 18 people.

Its size is small, so on its own it can only give an early look.

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.