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

What Was Tested

This registered phase 3 trial tested Liraglutide.

This trial is conducted in Japan.

The trial aims for comparison of the effect on glycaemic control of liraglutide, compared to sulfonylurea (SU treatment), as assessed by HbA1c after 24 and 52 weeks in subjects with type 2 diabetes.

Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.

It had two arms (groups): Liraglutide (experimental) and Glibenclamide (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 400 actual participants took part.

It was open to people of any sex aged from 20 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. Diet/exercise therapy with or without an oral anti-diabetic drug for at least eight weeks. BMI (Body Mass Index) less than 35 kg/m2.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: treatment with insulin within the last 12 weeks; treatment with any drug that could interfere with the glucose level; any serious medical condition.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

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

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 2006-11 with completion listed for 2007-11.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment (time frame: after 24 weeks of treatment).

It also tracked 12 secondary outcomes, for example Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment, Fasting Plasma Glucose After 24 Weeks of Treatment, Fasting Plasma Glucose After 52 Weeks of Treatment, Postprandial Glucose AUC After 24 Weeks of Treatment, Postprandial Glucose AUC After 52 Weeks of Treatment and Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 400 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, all human trials.