Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus

What Was Tested

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

Secondary Objectives: To compare HOE901-U300 and Lantus in terms of: * Percentage of participants reaching target HbA1c and fasting plasma glucose (FPG). * To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events of hyperglycemia with ketosis, and development of anti-insulin-antibodies.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 463 actual participants took part.

It was open to people of any sex aged from 6 years up to 17 years.

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

Examples of who could join: Signed written informed consent obtained from parent(s)/legal guardian and written or oral assent obtained from participant.

The full record lists 2 inclusion and 12 exclusion criteria; among the exclusions: age \<6 years and \>=18 years at randomization; less than 1 year on insulin treatment prior to screening visit; less than 6 months on basal plus mealtime insulin and self-monitoring of blood glucose prior to screening visit.

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 2016-04-14 with completion listed for 2018-05-31.

It ran at 107 sites in United States (13), Argentina (7), Hungary (7), Brazil (6), Japan (6) and Poland (6).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 10 secondary outcomes, for example Change From Baseline in Fasting Plasma Glucose (FPG) to Month 6, Change From Baseline in 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles to Month 6, Change From Baseline in Variability of 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles at Month 6, Change From Baseline to Month 6 in 8-Point SMPG Profile Per Time Point and Percentage of Participants With Any Hyperglycemia With Ketosis at Month 12.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 463 people.

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.