Effect of Liraglutide on the Beta-cell Responsiveness in Subjects With Type 2 Diabetes Compared to a Healthy Control Group

What Was Tested

The trial (phase 1) is built around Liraglutide.

This trial is conducted in the United States of America (USA).

It had three arms (groups): NNC 90-1170 (experimental), Placebo (placebo comparator) and Healthy (no intervention).

The registry classes the interventions as drug.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Diagnosed with type 2 diabetes, either newly diagnosed with at least 2 months of diet or on OAD monotherapy for at least 3 months. Body Mass Index (BMI): 24-35 kg/m\^2 inclusive.

The full record lists 2 inclusion and 14 exclusion criteria; among the exclusions: SUBJECTS WITH TYPE 2 DIABETES; receipt of any investigational drug within three months prior to this trial; recurrent severe hypoglycemia as judged by the investigator.

How the Study Was Run

The set-up was randomized, crossover and double-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.

In the crossover set-up each of the participants took both Liraglutide and the comparison in turn, acting as their own control.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2001-02 with completion listed for 2001-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: AUC (area under the curve) of Insulin Secretion Rate (ISR) over the [amount hidden]/dL glucose interval.

It also tracked 5 secondary outcomes, for example Slope of the mean ISR vs mean glucose, Insulin Clearance, NNC 90-1 170 plasma concentration and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 20 people.

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

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.