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

What Was Tested

In this phase 4 trial, researchers set out to test 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 noninsulin antidiabetic agents.

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

705 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.

The full record lists 0 inclusion and 12 exclusion criteria; among the exclusions: age \<18 years; type 1 diabetes mellitus; use of any product containing insulin since the time of diagnosis with t2dm other than temporary use during a pregnancy or hospitalization.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2015-11-05 with completion listed for 2017-10-16.

It ran at 128 sites in France (50), Spain (25), United Kingdom (20), Germany (14), Brazil (9) and Romania (8).

Its stated primary purpose is treatment.

What Was 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 705 people.

With 705 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.