A Trial Comparing HR17031 With Insulin Glargine in Patients With Type 2 Diabetes

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

It had two arms (groups): Treatment group A: HR17031 injection (experimental) and Treatment group B: insulin glargine (active comparator).

The registry classes the interventions as drug.

Who Took Part

393 actual participants took part.

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: Male or female, aged 18-75 years at the time of signing the informed consent (both ends included). Body Mass index (BMI) of 20.0-40.0 kg/m2 (both ends included). Diagnosed with type 2 diabetes for at least 90 days prior to screening. Ability and willingness to comply with protocol requirements, including self-monitoring of blood glucose, recording subject diary, and using pre-filled injection pen.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: known or suspected allergy to the investigational drug product or its components or excipients;; systemic glucocorticoid use within 3 months prior to screening; use of weight loss drugs within 3 months prior to screening.

How the Study Was Run

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

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

The Insulin Glargine group and the comparison group ran side by side rather than switching.

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

It started in 2024-05-08 with completion listed for 2025-05-13.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Changes in HbA1c from baseline to week 26 (time frame: from baseline to week 26).

It also tracked 8 secondary outcomes, for example Change in body weight from baseline to week 26, Changes in FPG from baseline to week 26, Hypoglycemic event from screening to week 27 and Adverse events from screening to week 27.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 393 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.