Relative Bioavailability and Activity of Different Formulations of Insulin Glargine and Lixisenatide in Patients With Diabetes Mellitus Type 1

What Was Tested

This registered phase 1 trial tested Insulin Glargine and Lixisenatide.

It had two arms (groups): Lantus(insulin glargine)/lixisenatide on-site mix (experimental) and lixisenatide + Lantus (insulin glargine) (active comparator).

The registry classes the interventions as drug.

More on the Plan

The study period for one patient is one month in average and it can last up to 7 months (+ 2 weeks) with post-study and follow-up visits.

Who Took Part

The registry lists 22 planned participants were the target.

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.

The full record lists 1 inclusion and 10 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

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

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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

Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2010-06 with completion listed for 2010-09.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the plasma lixisenatide concentration curve (LIX-AUClast) (time frame: 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period). Lixisenatide maximum plasma/serum peak concentration (LIX-Cmax) (time frame: 1 day (D1 to D2) in the first treatment period and 1 day (D1 to D2) during the second treatment period).

It also tracked 6 secondary outcomes, for example Area under the plasma lixisenatide concentration curve (AUC), Time to Cmax (Tmax ) for lixisenatide, Area under the body weight standardized glucose infusion rate curve (GIR) within 24 h (GIR-AUC0-24), Maximum smoothed body weight standardized glucose infusion rate GIRmax and Time to GIRmax (GIR-Tmax).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine and Lixisenatide in 22 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 and the Lixisenatide compound page, all human trials.