A Study 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 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 401 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

The set-up was randomized, parallel-group and open-label.

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

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

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

It started in 2024-04-30 with completion listed for 2025-09-19.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 31 secondary outcomes, for example Change in body weight from baseline after 26 weeks of treatment, Changes in Fasting Plasma Glucose (FPG) after 26 weeks of treatment, Change in mean of the 7-point SMPG profile from baseline (week 0) to week 26;, Change from baseline (week 0) in post-prandial SMPG increments for all meals after 26 weeks of treatment, Changes in HbA1c from baseline after 52 weeks of treatment and Changes in FBG from baseline after 52 weeks of treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 401 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.