Single Dose Study With a New Insulin Glargine Formulation and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus

What Was Tested

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

It had three arms (groups): Sequence 1 (experimental), Sequence 2 (experimental) and Sequence 3 (experimental).

The registry classes the interventions as drug.

More on the Plan

The study duration per patient will be 4 to 12 weeks including 3 treatment periods each separated by a wash-out period of 6-20 days.

Who Took Part

Enrollment: 18 actual participants took part.

It was open to people of any sex aged from 20 years up to 65 years.

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

Examples of who could join: Japanese male or female subjects, between 20 and 65 years of age, inclusive, with type 1 diabetes mellitus for more than one year, as defined by the Japanese Diabetes Society. Body weight between 50.0 kg and 95.0 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 4 months; known hypersensitivity to insulin glargine or excipients of the study drug.

How the Study Was Run

Design: randomized, crossover and double-blind.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2011-11 with completion listed for 2012-04.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Glucose infusion rate (time frame: up to day 2 of each period).

It also tracked 5 secondary outcomes, for example Number of patients with adverse events and Safety-related parameters including electrocardiogram, vital signs and laboratory tests.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 18 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.