Suppression of Endogenous Glucose Production by Injectable HDV-Insulin Lispro: A Dose Response Study in Human Subjects With Type 1 Diabetes

What Was Tested

The trial (phase 1) is built around Insulin Lispro.

EGP and GDR will be determined using established radioisotope methodology.

It had four arms (groups): one (placebo comparator), one (active comparator), one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 18 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female of age 18 to 65 years, inclusive, who:. Has at Screening been diagnosed as T1D for at least 12 months; preference will be given to potential participants who currently use continuous subcutaneous insulin infusion (CSII) therapy;. Has at Screening C-peptide ≤0.8 ng/mL (single retest allowed);. Has at Screening a BMI ≥18.0 kg/m2 and ≤33.0 kg/m2;.

The full record lists 5 inclusion and 12 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;; has, at screening, as judged by the site investigator, a history or current evidence of any of advance complications of diabetes;.

How the Study Was Run

It was run as a randomized, single-group and double-blind study.

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

Neither the participants nor the staff measuring them knew who was on Insulin Lispro, so expectations could not easily colour the readings.

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

Those kept unaware of assignments: participant and investigator.

It started in 2025-02-01 with completion listed for 2026-06-30.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of suppression of endogenous glucose production (time frame: 0 through 6 hours).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 18 people.

Its size is small, so on its own it can only give an early look.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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