Evaluation of the Safety and Efficacy of Insulin Glargine 300 U/ml (Gla-300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus Uncontrolled on Oral Antihyperglycemic Drugs

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

It had 1 arm (groups): Insuline Glargine (U300) (Gla-300) (experimental).

The registry classes the interventions as drug.

More on the Plan

The maximum study duration per participant is 27 weeks including a screening period of up to 2 weeks, a 24-week treatment period and a post-treatment follow-up phone call visit after 3 days after the end of treatment.

Who Took Part

228 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 3 inclusion and 4 exclusion criteria; among the exclusions: history of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening visit; proliferative retinopathy or maculopathy requiring treatment according to the investigator; use of systemic glucocorticoids (excluding topical application or inhaled forms) for 2 weeks or more within 8 weeks prior to screening visit.

How the Study Was Run

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

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

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

It started in 2021-06-07 with completion listed for 2022-12-23.

It ran at 2 sites in India (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of participants with Treatment Emergent Adverse Events (TEAEs) (time frame: Baseline to Week 24).

It also tracked 11 secondary outcomes, for example Percentage of participants with at least one confirmed hypoglycemia event, Change in HbA1c from Baseline to week 12 and week 24, Change in fasting plasma glucose (FPG) from Baseline to Week 24, Change in fasting SMBG from Baseline to Week 24, Change in 7-point SMBG profile from Baseline to Week 24 and Percentage of participants requiring rescue therapy.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Insulin Glargine in 228 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.