Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects

What Was Tested

This registered phase 2 trial tested Insulin Glargine.

It had three arms (groups): SHR-3167 group A (experimental), SHR-3167 group B (experimental) and Insulin glargine group (active comparator).

The registry classes the interventions as drug.

Who Took Part

275 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Able and willing to provide a written informed consent. Diagnosed with type 2 diabetes mellitus ≥ 6 months prior to the day of screening. Body mass index (BMI): 18.5\~35.0 kg/m2.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: poor blood pressure control at screening; diagnosis or suspicion of type 1 diabetes mellitus, latent autoimmune diabetes mellitus in adult (lada)，other special types of diabetes or secondary diabetes mellitus; ≥1 episode of severe hypoglycemia or asymptomatic hypoglycemia within 6 months prior to screening, or recurrent hypoglycemic events within 1 month prior to screening.

How the Study Was Run

Design: 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.

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

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

It started in 2025-01-08 with completion listed for 2026-04-22.

It ran at 2 sites in China (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change from baseline to week 20 in HbA1c (HemoglobinA1c) (time frame: Week 0 to week 20).

It also tracked 4 secondary outcomes, for example Change from baseline to week 20 in fasting plasma glucose (FPG), Change from baseline to week 20 in self-measured blood glucose (SMBG) before breakfast and Number of adverse events (AEs) during the trial.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Glargine in 275 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.