A Trial Comparing the Efficacy and Safety of Liraglutide [amount hidden] to Liraglutide [amount hidden] in Japanese Subjects With Type 2 Diabetes Mellitus.

What Was Tested

The trial (phase 3) is built around Liraglutide.

This trial is conducted in Asia.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 635 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: Male or female Japanese subjects at least 20 years of age at the time of informed consent. Type 2 diabetes subjects (diagnosed clinically) for at least 6 months prior to screening.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: treatment with insulin within 12 weeks prior to screening; screening calcitonin equal or above 50 ng/l; history of pancreatitis (acute or chronic).

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

Being open-label, the Liraglutide study did not mask who received what.

It started in 2015-07-21 with completion listed for 2017-05-02.

It ran at 47 sites in Japan (47).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Glycosylated Haemoglobin (HbA1c) (Week 26) (time frame: Week 0, Week 26).

It also tracked 60 secondary outcomes, for example Change in HbA1c (Week 52), Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile), Change in SMBG 7-point Profile: Mean of 7-point Profile, Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner), Change in Fasting Plasma Glucose (FPG) and Change in Waist Circumference.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 635 people.

With 635 participants it is a large trial for this field.

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.