Euglycemic Clamp Study Comparing Two New Insulin Glargine Formulations in Subjects With Type 1 Diabetes Mellitus

What Was Tested

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

It had two arms (groups): Insulin glargine new formulation (test T formulation) (experimental) and Insulin glargine new formulation (reference R formulation) (experimental).

Once daily for 6 days.

Once daily for 6 days.

The registry classes the interventions as drug.

Who Took Part

The registry lists 50 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Male or female subjects, between 18 and 64 years of age, inclusive, with diabetes mellitus type 1 for more than one year. 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. Laboratory parameters within the normal range.

The full record lists 10 inclusion and 10 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; frequent severe headaches and / or migraine, recurrent nausea and / or vomiting (more than twice a month); likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol.

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.

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2013-04 with completion listed for 2013-08.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 9 secondary outcomes, for example Maximum insulin concentration (INS-Cmax), Time to INS-Cmax (INS-tmax), Maximum smoothed body weight standardized glucose infusion rate (GIRmax) and Time to GIRmax (GIR-Tmax).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 50 people.

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.