A Clinical Efficacy and Safety Study of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

The registry classes the interventions as drug.

More on the Plan

Maximum study duration per participant will be approximately 37 weeks per patient: up to 1 week screening period, 24 weeks insulin glargine U300 treatment period and 12 weeks observational extension period.

Who Took Part

The registry lists 570 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: Adult patients (age≥18 years) who diagnosed with type 2 diabetes. Patients who should initiate Insulin glargine U300 treatment following local label and guideline at investigator's discretion, including:.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: use of systemic glucocorticoids (excluding topical application or inhaled forms) for two weeks or more within 8 weeks prior to the time of screening; known hypersensitivity / intolerance to insulin glargine or any of its excipients; pregnant or lactating women.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2021-05-20 with completion listed for 2023-02-24.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean change in HbA1c from baseline to week 24 (time frame: Baseline to Week 24).

It also tracked 11 secondary outcomes, for example Mean change in HbA1c from baseline to week 12 and week 36, Mean change in Fasting Plasma Glucose (FPG) from baseline to week 12, 24 and 36, Mean change in fasting Self-Monitored Blood Glucose (SMBG) from baseline to week 12 and week 24, Mean change in of 7-points SMBG per time point from baseline to week 12 and week 24, Number of participants experiencing hypoglycemia from baseline to week 12, 24 and 36 and Number of hypoglycemic events per patient-year.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Insulin Glargine in 570 people.

With 570 participants it is a large trial for this field.

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.