A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)

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 (active comparator).

The registry classes the interventions as drug.

More on the Plan

The total study duration per patient will be up to 53 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

3304 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 an Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: males or females \<18 years of age; type 1 diabetes mellitus; all contraindications to commercially available insulin therapy or warnings/precautions of use as displayed in the respective national product labeling for these products.

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.

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 2015-06-16 with completion listed for 2018-03-02.

It ran at 427 sites in United States (407) and Canada (20).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 12 secondary outcomes, for example Change From Baseline in HbA1c at Month 6 and Month 12, Treatment Persistence Measured by Medication Possession Ratio (MPR), Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6 and Month 12, Change From Baseline in Body Weight at Month 6 and Month 12 and Percentage of Participants With Hospitalizations, Emergency Rooms and Specialty Visits From Baseline to Month 6 and Month 12.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Detemir in 3304 people.

With 3304 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 and the Insulin Detemir compound page, all human trials.