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Ultrarapid Insulin Administered by a Bihormonal Closed Loop System in Patients With Type 1 Diabetes

NCT05508061 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-02-17

Study results available
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Summary

The main objective is to determine the efficacy of Lyumjev (insulin) in a bi-hormonal reactive closed loop system for automated glucose regulation (artificial pancreas; AP®) in patients with diabetes mellitus type 1. In addition, safety parameters, pharmacodynamics and AP-related parameters will be acquired.

This study is a multicenter, open-label, randomized, cross-over trial in 12 subjects. The subjects will be randomized to receive either Lyumjev or Humalog® for a 30-day study period and will then switch to the alternate insulin treatment after a wash-out period.

Conditions

Interventions

DRUG

Insulin Lispro Cartridge [Lyumjev]

Administration of Lyumjev in combination with the AP system

DRUG

Insulin Lispro Cartridge

Administration of Humalog in combination with the AP system (standard therapy)

Sponsors & Collaborators

  • Inreda Diabetic B.V.

    lead INDUSTRY

Principal Investigators

  • A. van Bon, MD, PhD · Rijnstate Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-19
Primary Completion
2023-03-16
Completion
2023-03-16

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05508061 on ClinicalTrials.gov