Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin

What Was Tested

This registered phase 2 trial tested Insulin Glargine.

Primary Objective: * To compare the glucose control during treatment with a new formulation of insulin glargine and Lantus in adult participants with type 1 diabetes mellitus Secondary Objectives: * To compare a new formulation of insulin glargine and Lantus given in the morning or in the evening * To compare the incidence and frequency of hypoglycemic episodes * To assess the safety and tolerability of the new formulation of insulin glargine.

It had four arms (groups): HOE901-U300 Morning Then Evening (experimental), HOE901-U300 Evening Then Morning (experimental), Lantus Morning Then Evening (active comparator) and Lantus Evening Then Morning (active comparator).

The registry classes the interventions as drug.

Who Took Part

59 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Participants with Type 1 diabetes mellitus.

The full record lists 1 inclusion and 12 exclusion criteria; among the exclusions: less than 1 year on any basal plus mealtime insulin; use of an insulin pump in the last 6 months before screening visit;; any contraindication to use of insulin glargine as defined in the national product label.

How the Study Was Run

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

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.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2012-08 with completion listed for 2013-05.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Time in Target Plasma Glucose Range ([amount hidden]/L [[amount hidden]/dL]).

It also tracked 9 secondary outcomes, for example Evaluation of Diurnal Glucose Exposure, Variability, and Stability, Change in HbA1c From Baseline to Week 8 and 16, Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16, Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16 and Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Glargine in 59 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.