Effect of Liraglutide on Pulsatile Insulin Secretion in Subjects With Type 2 Diabetes

What Was Tested

The trial (phase 1) is built around Liraglutide.

This trial is conducted in Europe.

The aim of this trial is to assess the effect of NNC 90-1170 (liraglutide) on pulsatile insulin secretion and insulin secretion after a standard meal in subjects with type 2 diabetes.

It had two arms (groups): NNC 90-1170 (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

11 actual participants took part.

It was open to people of any sex aged from 30 years up to 75 years.

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

Examples of who could join: BMI (Body Mass Index) between 24 and 35 kg/m\^2 (both inclusive). Anti-GAD (glutamic acid decarboxylase) negative.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: known or suspected allergy to trial product or related products; receipt of any investigational drug within three months prior to this trial; recurrent severe hypoglycaemia as judged by the investigator.

How the Study Was Run

Design: randomized, crossover and double-blind.

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

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

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 1999-09 with completion listed for 1999-12.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Insulin secretory burst mass.

It also tracked 5 secondary outcomes, for example Insulin secretory pulse mass, amplitude, frequency and regularity, Insulin secretion, Glucagon response, Gastric emptying rate and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 11 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.