Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

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 807 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: Participants with type 2 diabetes mellitus. Substudy inclusion criteria:. Completion of the 6-month study period in main study (Visit 10). Randomized and treated with insulin glargine new formulation during the 6-month treatment period (Baseline - month 6).

The full record lists 4 inclusion and 12 exclusion criteria; among the exclusions: age less than (\<) 18 years; diabetes other than type 2 diabetes mellitus; less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose.

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.

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 2011-12 with completion listed for 2013-01.

It ran at 193 sites in United States (95), Canada (22), Hungary (17), Czechia (10), Romania (9) and Netherlands (8).

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 10 secondary outcomes, for example Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint, Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint, Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint, Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint, Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint and Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 807 people.

With 807 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.