Study to Assess the Efficacy and Safety of Liraglutide in the Treatment of Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Liraglutide.

Food and Drug Administration in 2010.This 26-week trial compares the effectivity on glycaemic control,safety and immunogenicity of liraglutide injection and Victoza® in patients with type 2 diabetes inadequately controlled by oral metformin alone.

It had two arms (groups): TQZ2451+metformin hydrochloride (experimental) and Victoza®+metformin hydrochloride (active comparator).

The registry classes the interventions as drug.

Who Took Part

424 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Diagnosed as type 2 diabetes. Body mass index (BMI) of 18.5-45 kg/m2(both inclusive). The patient must give informed consent to the study before the trial and voluntarily sign the informed consent form. The patient can communicate well with the researcher and complete the study in accordance with the research regulations.

The full record lists 6 inclusion and 23 exclusion criteria; among the exclusions: diagnosed as type 1 or other types of diabetes; treatment with systemic glucocorticoid therapy within 3 months before screening\[topical medication or inhaled product is excluded\] ; treatment with chinese medicine preparations having hypoglycemic effects within 1 month before screening.

How the Study Was Run

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

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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 2020-04-29 with completion listed for 2021-12-01.

It ran at 46 sites in China (46).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): glycated hemoglobin (HbA1c) (time frame: week 0,week 26).

It also tracked 14 secondary outcomes, for example Body weight, HbA1c change from baseline, Changes in fasting venous blood glucose (FPG), Changes in 2h-Postprandial Blood Glucose(2h-PBG), Changes in fasting insulin and Changes in fasting C peptide.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in 424 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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