Effect of Liraglutide on Glucose Profiles and Gastric Emptying in Subjects With Type 2 Diabetes

What Was Tested

In this phase 2 trial, researchers set out to test Liraglutide.

This trial is conducted in Europe.

The aim of this trial is to determine the effect of NNC 90-1170 (liraglutide) on glucose and hormonal profiles, fasting gluconeogenesis and insulin secretion in subjects with type 2 diabetes.

It had two arms (groups): Treatment period 1 (experimental) and Treatment period 2 (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 17 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. Body Mass Index (BMI) maximum 35 kg/m\^2.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: impaired liver function; impaired renal function; cardiac disease.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

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.

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 2001-05 with completion listed for 2002-02.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 24-hour glucose profiles after three fixed meals.

It also tracked 9 secondary outcomes, for example 24-hour insulin profiles after three fixed meals, First phase insulin and maximal insulin secretory capacity, 24-hour glucagon profiles after three fixed meals, 24-hour FFA (free fatty acids) profiles after three fixed meals, 4-hour paracetamol profiles after two fixed meals and 30-hour NNC 90-1170 profile.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 17 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.