Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine.

To assess the safety in each treatment group.

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

The registry classes the interventions as drug.

More on the Plan

The maximum study duration per participant was approximately 27 weeks: an up to 2-week screening period, a 24-week randomized treatment period (including 12 weeks active titration), and a 7-day posttreatment safety follow-up period.

Who Took Part

Enrollment: 929 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: Signed written informed consent.

The full record lists 2 inclusion and 13 exclusion criteria; among the exclusions: age \<18 years; history of t2dm for less than 1 year before screening; less than 6 months before screening on oads treatment and glp-1 receptor agonist (if taken).

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2016-05-19 with completion listed for 2017-08-15.

It ran at 158 sites in United States (74), Romania (13), Italy (12), Czechia (8), Israel (8) and United Kingdom (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in HbA1c to Week 24 (time frame: Baseline, Week 24).

It also tracked 17 secondary outcomes, for example Change From Baseline in HbA1c to Week 12, Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 and Week 24, Change From Baseline in Fasting Self-Monitoring Plasma Glucose (SMPG) to Week 12 and Week 24, Change From Baseline in 8 Point SMPG Profile to Week 12 and Week 24 Per Time Point, Change From Baseline in 4-point SMPG Profile to Week 12 and Week 24 Per Time Point and Change From Baseline in 24-hour Average 8-point SMPG Profile to Week 12 and Week 24.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 929 people.

With 929 participants it is a large trial for this field.

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.