To Investigate the Blood Concentration of Liraglutide as Well as the Effects on Glucose and Insulin After 21 Days of Daily Subcutaneous Injections of Liraglutide or Placebo

What Was Tested

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

This trial is conducted in Asia.

In addition, the safety and tolerability of liraglutide will be observed.

It had six arms (groups): A1 (experimental), A2 (placebo comparator), B1 (experimental), B2 (placebo comparator) and C1 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 37 actual participants took part.

It was open to men only aged from 18 years up to 45 years.

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

Examples of who could join: Informed consent obtained before any trial related activities. Healthy Chinese male subjects. Body mass index (BMI) between 19.0 and 27.0 kg/m2 (both inclusive).

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: pulse in supine position at the screening, after resting for 5 min, outside the range 40 - 100 times/min; hepatitis b surface antigen, hepatitis c antibodies or hiv antibodies positive.

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.

The Liraglutide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2008-10 with completion listed for 2008-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example Adverse events and Hypoglycaemic events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 37 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.