Single Dose Clamp Study To Compare Concentration/Time Profile And Metabolic Activity Profile Of 2 New Formulations Of Insulin Glargine With Lantus

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Glargine.

It had three arms (groups): insulin glargine U100 (active comparator), insulin glargine U200 (experimental) and insulin glargine U500 (experimental).

The registry classes the interventions as drug.

More on the Plan

Total study duration for each subject is between 3.5 and 12 weeks.

Two overnight stays at the unit in each of 3 treatment periods.

Who Took Part

Enrollment: 36 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Male or female subjects, between 18 and 65 years of age, inclusive, with type 1 diabetes mellitus for more than one year, as defined by the American Diabetes Association. Body weight between 50.0 kg and 110.0 kg, Body Mass Index between 18.5 and 30.0 kg/m2 inclusive. Stable insulin regimen for at least 2 months prior to inclusion in study. Certified as otherwise healthy for Type 1 diabetes mellitus patient. Having given written informed consent prior to undertaking any study-related procedure.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Glargine.

Those kept unaware of assignments: participant and investigator.

It started in 2014-08 with completion listed for 2014-11.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

It also tracked 9 secondary outcomes, for example AUC up to the last measurable concentration, Time to reach INS-Cmax (INS-tmax), Maximum smoothed body weight standardized glucose infusion rate (GIRmax) and time to GIRmax (GIR-Tmax) and Duration of blood glucose control (time to elevation of smoothed blood glucose profile above different pre-specific blood glucose levels).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 36 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.