Complaints Associated With Use of Pre-Filled Pen B With Type 2 Diabetics on Twice-Daily Insulin

What Was Tested

The trial (phase 3) is built around Insulin Lispro.

Trial of new insulin injection pen called Pre-filled Pen B by type 2 diabetics in take home situations.

Patients must use insulin lispro injection \[rDNA origin\] Low Mix twice daily during the trial.

The registry classes the interventions as drug.

Who Took Part

370 planned participants were the target.

It was open to people of any sex aged from 25 years up to 75 years.

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

Examples of who could join: Type 2 Diabetes. 25 to 75 years old inclusive.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: currently using, or had used during previous month, oral diabetes medication that is not approved for use in combination with insulin in patient's country; more than 3 unexplained episodes of severe hypoglycemia within 6 months prior to trial.

How the Study Was Run

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

Being open-label, the Insulin Lispro study did not mask who received what.

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

It started in 2005-09 with completion listed for 2006-04.

It ran at 4 sites in Spain (2), United States (1) and United Kingdom (1).

What Was Measured

The main thing measured (primary outcome): To collect complaint data on the Pre-filled Pen B when used by persons with type 2 diabetes to self-administer insulin in take-home situations for 2 months.

It also tracked 2 secondary outcomes, for example To monitor safety, including all adverse events, hypoglycemia, device-related hypoglycemia, and device-related hyperglycemia and To assess overall patient perception of the device's performance through a patient questionnaire.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Insulin Lispro in 370 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Lispro compound page, all human trials.