To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Oral Antidiabetic Drugs

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

It had two arms (groups): INS068 injection (experimental) and Insulin Glargine (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 513 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: Diagnosed with type 2 diabetes ≥ 6 months；.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: known or suspected allergy or intolerance to the investigational medicinal products or related products；; hospitalization for diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome during the previous 6 months；; potentially unstable diabetic retinopathy or maculopathy requiring treatment (e.g., laser, surgical treatment or injectable drugs) during the previous 6 months；.

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.

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

It started in 2023-03-31 with completion listed for 2024-11-23.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in HbA1c (time frame: Week 0 to Week 26).

It also tracked 14 secondary outcomes, for example Change in FPG(fasting plasma glucose), Change in HbA1c, per-breakfast SMPG, 8-point SMPG profiles, Proportion of Subjects requiring rescue therapy during treatment and Frequency and severity of adverse events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 513 people.

With 513 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.