Comparison of Glucose Values and Variability Between TOUJEO and TRESIBA During Continuous Glucose Monitoring in Type 1 Diabetes Patients

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

Secondary Objective: To evaluate the glycemic control and variability parameters in each treatment group at Week 12 using Continuous Glucose Monitoring.

It had two arms (groups): Toujeo (experimental) and Tresiba (active comparator).

The registry classes the interventions as drug.

More on the Plan

The duration of the study per participant was around 18 weeks: 1 or 2 weeks of screening followed by a 4-week run-in period, a 12-week treatment period and a 2 to 4 days follow-up period.

Who Took Part

343 actual participants took part.

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: Participants with Type 1 Diabetes mellitus. Participants treated with multiple daily injections using basal insulin analog once daily and rapid acting insulin analogs for at least one year.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: participants having received toujeo or tresiba as basal insulin within 30 days prior to screening; participants not having used the same insulins (both basal and rapid) within 30 days prior to screening; end stage renal disease or on renal replacement treatment.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2019-10-09 with completion listed for 2021-09-16.

It ran at 7 sites in United States (1), Brazil (1), Germany (1), Hungary (1), Netherlands (1) and Turkey (Türkiye) (1).

Its stated primary purpose is treatment.

What Was Measured

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 343 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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