Comparison of Different Insulin Dosing Algorithms Using Hepatic Directed Vesicle-Insulin Lispro and Insulin Degludec

What Was Tested

This registered phase 2 trial tested Insulin Lispro.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

There is a 12-week run-in phase when all subjects receive Insulin Lispro and Insulin Degludec for 12 weeks.

Who Took Part

The registry lists 61 actual participants took part.

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.

Examples of who could join: Male or female of age 18 to 65 years, inclusive. Has at Screening been diagnosed as T1DM for at least 12 months. Has at Screening C-peptide ≤0.8 ng/mL (single retest allowed). Has at Screening been on treatment with rapid analog insulin for the previous six (6) months. Has at Screening willingness to use continuous glucose monitoring (CGM) technology throughout study.

The full record lists 9 inclusion and 17 exclusion criteria; among the exclusions: has known or suspected allergy to any component of any of the study drugs in this trial; is, at screening, pregnant or breast-feeding, or intends to become pregnant at any time during the duration of the study; is, at screening, judged by the site investigator to have a current addiction to alcohol or substances of abuse.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Lispro group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2019-03-18 with completion listed for 2019-12-06.

It ran at 7 sites in United States (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Basal/bolus ratios during the last 2 weeks of the treatment period (time frame: 24 weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Lispro in 61 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.