Evaluation of the Efficacy and Safety of Insulin Glargine 300 U/mL in Patients With Type 2 Diabetes Mellitus Uncontrolled on Other Kinds of Insulin

What Was Tested

The trial (phase 4) is built around Insulin Glargine.

Secondary Objectives: To evaluate the effects of Gla-300 on glycemic control, treatment satisfaction, and health care resource utilization (HCRU) outcomes.

To evaluate the safety of Gla-300.

It had 1 arm (groups): Insulin glargine (U300) (experimental).

Insulin glargine (U300) (Gla-300) once daily for 26 weeks on top of any other antidiabetic treatment except other basal insulin.

The registry classes the interventions as drug.

More on the Plan

Study duration per participant is approximately 29 weeks including a screening period of up to 2 weeks, a 26-week treatment period, and a post treatment follow-up phone call visit at Week 27.

Who Took Part

Enrollment: 372 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: Participants with type 2 diabetes mellitus.

The full record lists 4 inclusion and 2 exclusion criteria.

How the Study Was Run

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

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.

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

It started in 2018-12-18 with completion listed for 2020-09-23.

It ran at 14 sites in Argentina (1), Colombia (1), Egypt (1), Hong Kong (1), India (1) and Indonesia (1).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 11 secondary outcomes, for example Change in glycated hemoglobin (HbA1c), Change in fasting SMPG, Change in SMPG profile, Change in fasting plasma glucose (FPG), Percentage of participants requiring rescue therapy and Number of participants with hypoglycemia events.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Insulin Glargine in 372 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.