Safety and Tolerability of Liraglutide in Healthy Volunteers and Subjects With Type 2 Diabetes

What Was Tested

In this phase 1 trial, researchers set out to test Liraglutide.

This trial is conducted in Europe.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 24 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy subjects aged 18-45 years inclusive. Women who are not of childbearing potential. Signed and dated written informed consent obtained. Body mass index (BMI) within the range 19-30 kg/m\^2, inclusive. SUBJECTS WITH DIABETES.

The full record lists 16 inclusion and 24 exclusion criteria; among the exclusions: HEALTHY VOLUNTEERS; clinically relevant abnormalities of laboratory values or ecg at the screening evaluation; blood pressure and heart rate in seated position at the screening examination outside the ranges 90-150 mmhg systolic, 40-90 mmhg diastolic: heart rate 40-100 beats/min.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

Those kept unaware of assignments: participant and investigator.

It started in 1999-08 with completion listed for 1999-11.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the Curve.

It also tracked 4 secondary outcomes, for example Cmax, maximum concentration, tmax, time to maximum concentration, t½, terminal half-life and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 24 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.