Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin (0000-168)

What Was Tested

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

The purpose of this study is to evaluate whether the within-subject variation in duration of action and time-action profile of glargine measured by isoglycemic clamp will be below prespecified levels.

It had two arms (groups): Part 1 (active comparator) and Part 2 (active comparator).

Part I of the trial.

Part II of the trial.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 36 actual participants took part.

It was open to men only aged from 18 years up to 45 years.

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

Examples of who could join: Patient is a male between 18 to 45 years of age (inclusive) at the prestudy (screening) visit. Patient has a clinical diagnosis of type 1 diabetes. Patient has a Body Mass Index (BMI) of \<=27 kg/m2 and \>18 kg/m2. Patient has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months. Subject is a male between 18 to 45 years of age at the prestudy (screening) visit.

The full record lists 8 inclusion and 11 exclusion criteria; among the exclusions: patient has a history of stroke, chronic seizures, or major neurological disorder; patient has a history of hypertension requiring treatment; patient has a history of neoplastic disease within the past 5 years.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2010-08 with completion listed for 2012-05.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Part I: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action) (time frame: Baseline and 30 hours). Part II: The within-subject coefficient of variation in time-action profile of glargine for AUC-GIR (AUC of glucose infusion rate), GIRmax (maximum level of glucose infusion rate), over the duration of action of glargine (time frame: Baseline and 30 hours).

It also tracked 2 secondary outcomes, for example Part II: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action).

What This Means in Plain Language

Put simply, this is a phase 1, non-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.