Effect of Liraglutide on Blood Glucose Control in Japanese Subjects With Type 2 Diabetes

What Was Tested

This registered phase 2 trial tested Liraglutide.

This trial is conducted in Japan.

The aim of this research trial is to evaluate the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in Japanese subjects with type 2 diabetes.

Liraglutide or placebo is administered by injection once daily in the evening.

The registry classes the interventions as drug.

Who Took Part

226 actual participants took part.

It was open to people of any sex aged from 20 years up to 74 years.

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

Examples of who could join: Subjects diagnosed with type 2 diabetes and treated with diet therapy with or without single oral drug therapy. Body Mass Index (BMI) \< 30.0 kg/m\^2.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: subjects treated with thiazolidinediones or insulin; subjects with any serious medical conditions.

How the Study Was Run

Design: randomized, parallel-group 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.

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

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 2005-01 with completion listed for 2006-05.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): HbA1c (time frame: after 14 weeks treatment).

It also tracked 3 secondary outcomes, for example Glycaemic control parameters (fasting plasma glucose, post prandial plasma glucose) after 14-week treatment, Body weight after 14 weeks and Safety and tolerability.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 226 people.

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.