The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes

What Was Tested

This registered phase 4 trial tested Liraglutide.

This trial is conducted in Asia.

Eligible subjects will continue their metformin background treatment during the trial.

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

2-week screening period, 26-week treatment duration, and a 1-week follow-up period.

2-week screening period, 26-week treatment duration, and a 1-week follow-up period.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 368 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Male or female, age at least 18 years and below 80 years at the time of signing informed consent. Body mass index below or equal to 45.0 kg/m\^2.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: history of chronic pancreatitis or idiopathic acute pancreatitis; any chronic disorder or severe disease which at the discretion of the investigator might jeopardise subject's safety or compliance with the protocol; screening calcitonin value above or equal to 50 ng/l.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

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

Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.

It started in 2013-12 with completion listed for 2014-11.

It ran at 25 sites in China (25).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Glycosylated Haemoglobin (HbA1c) (time frame: Week 0, week 26).

It also tracked 5 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose, Change From Baseline in 7-point Self-measured Plasma Glucose Profile and Number of Confirmed Hypoglycaemic Episodes.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 368 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.