Efficacy and Safety Of Different Regimens In Patients With Type 2 Diabetes Receiving Intensive Insulin Therapy

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

It had three arms (groups): metformin+empagliflozin+insulin glargine (experimental), IDegLira (experimental) and premixed insulin analogues (active comparator).

Metformin+empagliflozin+insulin glargine.

IDegLira.

Premixed insulin analogues.

The registry classes the interventions as drug.

More on the Plan

Eligible patients will then be randomized in a 1:1:1 ratio to insulin glargine plus OADs or twice-daily premixed insulin or Insulin Degludec \& Liraglutide for 3 months with metformin maintained throughout the study in both treatment groups.

All the patients will wear CGM during short-term intensive insulin therapy and after treatment for 7 days.

The primary endpoint is plasma glucose change from baseline to month 3.

Who Took Part

Enrollment: 78 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Aged 18-70 years with poorly-controlled T2DM (World Health Organization diagnostic criteria). Duration of T2DM more than 1 year. Fasting C-peptide \>1 ng/mL.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: acute diabetic complications (diabetic ketoacidosis, lactic acidosis, hyperosmolar nonketotic diabetic coma) within the past 1 month;; inability to perform self-monitoring of bg (smbg); acute disease or surgery in the past 3months or preparation for the surgey.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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.

In this single-blind Insulin Glargine study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2022-09-01 with completion listed for 2024-06-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean Change From Baseline in HbA1c (time frame: Month 0 to 3). Amplitude of glycemic excursions (time frame: Month 0 to 3).

It also tracked 2 secondary outcomes, for example Percentage of hypoglycemia incidence and Percentage of adverse events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 78 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.