A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulin in Patients Already Using Basal Insulin

What Was Tested

This registered phase 4 trial tested Insulin Glargine and Insulin Detemir.

It had two arms (groups): Toujeo (experimental) and "Standard of care" commercially available basal insulin (active comparator).

Toujeo will be administered once daily in addition to non-insulin antidiabetic agents.

Lantus, Humulin Neutral Protamine Hagedorn (NPH), Levemir, and Tresiba or other basal insulin, including biosimilar insulin will be administered once or twice daily according to label in addition to non-insulin antidiabetic agents.

The registry classes the interventions as drug.

More on the Plan

The total study duration will be up to 55 weeks, consisting of a 1 week screening period at the site, a 26 week treatment period, and a 26 week extension period.

Who Took Part

The registry lists 609 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: Adult patients who have signed Informed Consent Form (ICF) and privacy form(s).

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: age \<18 years; type 1 diabetes mellitus; use of any product containing short or rapid acting insulin occurring within 3 months prior to the time of screening.

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.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

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

It started in 2015-12-21 with completion listed for 2017-10-20.

It ran at 118 sites in Spain (28), Italy (23), United Kingdom (22), France (14), Brazil (9) and Romania (8).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c (percentage %) (time frame: Baseline to 6 months).

It also tracked 11 secondary outcomes, for example Proportion of patients who remain on assigned basal insulin therapy before intensification (persistent with assigned therapy), Proportion of patients who remain on assigned basal insulin therapy whether intensification occurred or not, Change in HbA1c (percentage %), Percentage of patients requiring intensification, Time to intensification and Change in fasting plasma glucose.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Detemir in 609 people.

With 609 participants it is a large trial for this field.

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 and the Insulin Detemir compound page, all human trials.