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

NCT05508061 | Completed Results

• 1 other identifier: NL79588.091.22
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief 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

Type 1 Diabetes

Keywords

Ultra rapid-acting insulin; Lyumjev; Humalog®; Artificial pancreas (AP®); Bihormonal reactive closed loop system; Automated glucose regulation; Time above range

Outcome Measures

Primary Outcomes (1)

• Percentage of Time the Glucose Level is Above 10 mmol/l

  Time the glucose level is above range (\>10 mmol/l) expressed as a percentage (%)

  25 days for each intervention period (50 days in total); 5-day training period and washout period were excluded from analysis; data were continuously acquired

Secondary Outcomes (10)

• Side Effects of Insulin

  68 days (whole study period)

• Pharmacodynamic Parameters: Euglycemia

  25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)

• Pharmacodynamic Parameters: Hypoglycemia

  25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)

• Pharmacodynamic Parameters: Mean Glucose Value

  25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)

• Pharmacodynamic Parameters: Standard Deviation of Glucose Value

  25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)

Study Arms (2)

Lyumjev (insulin lispro)

EXPERIMENTAL

Administration of Lyumjev for a 30-day study period (dosage and frequency is patient-dependent)

Drug: Insulin Lispro Cartridge [Lyumjev]

Humalog (insulin lispro)

ACTIVE COMPARATOR

Administration of standard used Humalog for a 30-day study period and 8-day wash-out period located between the two study periods (dosage and frequency is patient-dependent)

Drug: Insulin Lispro Cartridge

Interventions

Insulin Lispro Cartridge DRUG

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

Also known as: Humalog

Humalog (insulin lispro)

Insulin Lispro Cartridge [Lyumjev] DRUG

Administration of Lyumjev in combination with the AP system

Also known as: Lyumjev

Lyumjev (insulin lispro)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with diabetes mellitus type 1;
• Treated with the Inreda AP system for a minimum of 1 month;
• Age between 18 and 75 years;
• Willing and able to sign informed consent.
• Treated with sensor augmented pump (SAP) or CSII for a minimum of 6 months;
• HbA1c \< 97 mmol/mol;
• BMI \< 35 kg/m\^2;
• No use of acetaminophen, as this may influence the sensor glucose measurements.

You may not qualify if:

• Impaired awareness of hypoglycemia (score ≥ 4) according to Gold and/or Clarke questionnaire;
• Pregnancy and/or breastfeeding;
• Use of oral antidiabetic agents;
• Insulinoma;
• Hypersensitivity reactions to Lyumjev or any of the excipients.

Sponsors & Collaborators

• Inreda Diabetic B.V.: lead

Study Sites (3)

Rijnstate Hospital

Arnhem, Gelderland, 6815 AD, Netherlands

Location

Slingeland Hospital

Doetinchem, Gelderland, 7009 BL, Netherlands

Location

Hospital Gelderse Vallei

Ede, Gelderland, 6716 RP, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

AP settings for standard treatment (Humalog) were already optimal as a result of long term regular care. However, in the Lyumjev-Humalog sequence, these optimal AP settings were not set again when starting with Humalog. Instead, optimized settings for Lyumjev were used. This procedural error with an unknown influence on glucose regulation rendered a reliable cross-over comparison impossible, which required the exclusion of AP data from these five participants before data analysis.

Results Point of Contact

• Title: Clinical Projects Specialist
• Organization: Inreda Diabetic B.V.

tom.jansen@inredadiabetic.nl

0031547262628

Study Officials

• A. van Bon, MD, PhD

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Allocation by randomization: * Study period 1 (Humalog or Lyumjev) * Wash-out period (Humalog: standard therapy) * Study period 2 (other type of insulin than in Study period 1 (Humalog or Lyumjev))

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 19, 2022
• Study Start: October 19, 2022
• Primary Completion: March 16, 2023
• Study Completion: March 16, 2023
• Last Updated: February 17, 2026
• Results First Posted: February 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)