A Trial Comparing Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs)

What Was Tested

In this phase 3 trial, researchers set out to test Liraglutide.

This trial is conducted in Asia.

It had three arms (groups): Insulin degludec/liraglutide (experimental), Insulin degludec (active comparator) and Liraglutide (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 720 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Type 2 diabetes mellitus (clinically diagnosed). Male or female, age at least 18 years at the time of signing informed consent.

The full record lists 10 inclusion and 10 exclusion criteria; among the exclusions: treatment with insulin (except for short-term treatment at the discretion of the investigator); treatment with glucagon-like-peptide-1 receptor agonists or dipeptidyl-peptidase-4 inhibitors within 90 days prior to screening; impaired liver function, defined as alanine aminotransferase above or equal to 2.5 times upper normal range.

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.

Everyone knew when Liraglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2017-05-26 with completion listed for 2019-06-14.

It ran at 36 sites in China (36).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c (time frame: Week 0, week 26).

It also tracked 61 secondary outcomes, for example Change in Body Weight, Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes, Change in Fasting Plasma Glucose (FPG), Change in Waist Circumferance, 9-point SMPG Profile and Change in Mean of 9-point SMPG Profile.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 720 people.

With 720 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.