Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus

What Was Tested

The trial (phase 3) is built around Insulin Glargine.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 549 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 participants with type 1 diabetes mellitus.

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: less than 1 year on any basal plus mealtime insulin and self-monitoring of blood glucose before screening visit; not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening;; severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit.

How the Study Was Run

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

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.

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 2012-09 with completion listed for 2013-09.

It ran at 147 sites in United States (82), Japan (11), Romania (9), Canada (6), Hungary (6) and Denmark (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change In HbA1c From Baseline to Month 6 Endpoint (time frame: Baseline, Month 6).

It also tracked 11 secondary outcomes, for example Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint, Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint, Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint, Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint and Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 549 people.

With 549 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.