Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Older Patients With Type2 Diabetes Insufficiently Controlled on Their Current Antidiabetic Medications

What Was Tested

In this phase 3 trial, researchers set out to test Insulin Glargine.

It had two arms (groups): HOE901-U300 (experimental) and Lantus (active comparator).

The registry classes the interventions as drug.

More on the Plan

The study consisted of a 4-week screening period, a 26-week treatment period comparing HOE901-U300 to Lantus, and a 2-day safety follow-up period.

Who Took Part

Enrollment: 1014 actual participants took part.

It was open to people of any sex aged from 65 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participants ≥65 years old with type 2 diabetes mellitus, inadequately controlled on antidiabetic regimens either including no insulin, or with basal insulin as their only insulin. Signed informed consent.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: hba1c at screening visit:; history of type 2 diabetes mellitus for less than 1 year before screening.

How the Study Was Run

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

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.

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2015-01 with completion listed for 2016-05.

It ran at 162 sites in United States (64), Canada (10), Hungary (8), Spain (8), Japan (7) and Peru (7).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c From Baseline to Week 26 (time frame: Baseline, Week 26).

It also tracked 8 secondary outcomes, for example Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26, Change in World Health Organization-5 (WHO-5) Well-Being Questionnaire Percentage Score From Baseline to Week 26 and Percentage of Participants Requiring Rescue Therapy Over the 26 Weeks of Treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 1014 people.

With 1014 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.