A Study Comparing the Pharmacodynamic Properties of Insulin VIAJECT™, Regular Human Insulin, and Insulin Lispro

Plain-language guide to NCT01000922: phase 2 non-randomized trial of Insulin (regular human) and Insulin Glargine, 24 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01000922
Phase: phase 2
Status: completed
Start: 2006-06
Completion (planned or actual): 2008-01
Participants: 24 (actual)
Design: non-randomized, open label (everyone knows who gets what), treatment
Conditions studied: Diabetes Mellitus
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2) is built around Insulin (regular human) and Insulin Glargine.

It had six arms (groups): Regular Human Insulin (experimental), Lispro (experimental), VIAject (experimental), one (experimental) and VIAject/Insulin glargine (experimental).

Single injection.

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 19 years up to 70 years.

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

Examples of who could join: Established diagnosis of type 1 diabetes for not less than 5 years. Age: 19 to 70 years. Sex: Male or Female. Body Mass Index: 18 - 28 kg/m2. Informed consent must be obtained in writing for all volunteers.

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: type 2 diabetes mellitus; history of hypersensitivity to any of the components in the study medication; history of severe or multiple allergies.

How the Study Was Run

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

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

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2006-06 with completion listed for 2008-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: To compare the maximal post prandial blood glucose concentration and the time to maximal post prandial glucose concentration between the different treatments (time frame: 8 hours).

It also tracked 1 secondary outcome, for example To compare the ppGlucmax for all treatments, the ppTGluc-max, the AUCGluc 0-180 and the AUCGluc 0-360, CGluc-baseline for all treatments.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Insulin (regular human) and 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 (regular human) compound page and the Insulin Glargine compound page, all human trials.

Our Notes on the Compounds

Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.

Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.

Insulin Lispro: A rapid-acting mealtime insulin analog; brands include Humalog, Admelog and Lyumjev.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.