Effect of Treatment With Insulin VIAjectTM Compared to Regular Human Insulin and Insulin Lispro on Mealtime Blood Vessel Stress in Patients With Type 2 Diabetes Mellitus.

Plain-language guide to NCT00849576: phase 3 non-randomized trial of Insulin (regular human) and Insulin Lispro, 15 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00849576
Phase: phase 3
Status: completed
Start: 2008-04
Completion (planned or actual): 2008-08
Participants: 15 (actual)
Design: non-randomized, open label (everyone knows who gets what), treatment
Conditions studied: Type 2 Diabetes
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Insulin (regular human) and Insulin Lispro.

The purpose of this study is to compare the effects of insulin VIAject with Regular Human Insulin and Insulin Lispro on measures of mealtime blood vessel stress and blood flow.

It had four arms (groups): Regular Human Insulin (active comparator), one (active comparator), one (experimental) and one (experimental).

Single Injection.

The registry classes the interventions as drug.

Who Took Part

15 actual participants took part.

It was open to people of any sex aged from 40 years up to 75 years.

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

Examples of who could join: Type 2 diabetes mellitus according to the ADA criteria. Age between 40 and 75 years. BMI \< 40.

The full record lists 5 inclusion and 19 exclusion criteria; among the exclusions: type 1 diabetes mellitus; pre-treatment with insulin within the last 6 months prior to screening; pre-treatment with ppary-agonists or glucosidase inhibitors within the last 4 weeks prior to screening.

How the Study Was Run

It was run as a non-randomized, crossover and open-label study.

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

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2008-04 with completion listed for 2008-08.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Postprandial time course of Asymmetric dimethyl arginine (ADMA) after injection of insulin VIAjectTM compared with regular human insulin and insulin lispro (time frame: 0 - 240 minutes).

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Insulin (regular human) and Insulin Lispro in 15 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 Lispro 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 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.