Euglycemic Clamp Dose-response Study Comparing a New Insulin Glargine Formulation With Lantus®

What Was Tested

The trial (phase 1) is built around Insulin Glargine.

It had 1 arm (groups): Insulin glargine / New insulin glargine formulation (experimental).

* Period 1: Insulin glargine * Period 2: New insulin glargine formulation * Period 3: New insulin glargine formulation * Period 4: New insulin glargine formulation Duration of treatment: 1 day at each period.

The registry classes the interventions as drug.

Who Took Part

The registry lists 24 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 with diabetes mellitus type 1 for more than one year,. Stable insulin regimen for at least 2 months prior to study,. Normal findings in medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculo-skeletal system), vital signs, electrocardiogram (ECG) and safety lab,.

The full record lists 7 inclusion and 11 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.

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 2010-08 with completion listed for 2010-11.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The area under the body weight standardized glucose infusion rate curve (GIR) within 36 hours (GIR-AUC0-36) (time frame: 36 hours (D1 to D2) in all four treatment periods).

It also tracked 6 secondary outcomes, for example The area under the insulin glargine concentration curve within 36 hours (INS-AUC0-36) -, Maximum smoothed body weight standardized glucose infusion rate GIRmax, and time to GIRmax (GIR-Tmax) and Maximum insulin concentration INS-Cmax, and time to Cmax (INS-Tmax).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 24 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.