Repeated Dosing Study With a New Insulin Glargine Formulation and Lantus® in Patients With Type 1 Diabetes Mellitus

What Was Tested

This registered phase 1 trial tested Insulin Glargine.

It had two arms (groups): Cohort 1 (experimental) and Cohort 2 (experimental).

The registry classes the interventions as drug.

More on the Plan

The study duration per patient will be 33 to 68 days including 2 treatment periods of 10 days each separated by a wash-out period of 7-21 days.

Who Took Part

The registry lists 30 planned participants were the target.

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 diabetes mellitus type 1 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 18.0 and 30.0 kg/m2 inclusive. Stable insulin regimen for at least 2 months prior to study. Certified as otherwise healthy for Type-1 Diabetes mellitus patient by assessment of medical history and physical examination.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: more than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months; participation in a trial with any investigational drug during the past three months; known hypersensitivity to insulin glargine or excipients of the study drug.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

In the crossover set-up each of the participants took both Insulin Glargine and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Insulin Glargine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2011-03 with completion listed for 2011-05.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory (time frame: up to day 10 of each period).

It also tracked 4 secondary outcomes, for example Glucose infusion rate.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 30 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.