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

Type 1 Diabetes Clinical Trial

— FAST 1  

Official title:

Fully Automated Glycemic Control With Ultrarapid Insulin in a Bihormonal Closed Loop System in Patients With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05508061
• Other study ID #: NL79588.091.22
• Status: Completed
• Phase: N/A
• Start date: October 19, 2022
• Est. completion date: March 16, 2023

Study information

• Verified date: April 2023
• Source: Inreda Diabetic B.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Background of the study:

Inreda Diabetic B.V. (Goor, The Netherlands) developed a bi-hormonal reactive closed loop system to automate glucose regulation (artificial pancreas; AP) in patients with diabetes mellitus type 1. In the current CE-marked AP, Humalog® (Eli Lilly) is used as rapid-acting insulin. Currently, the ultra rapid-acting insulin Lyumjev (Eli Lilly) is available but has not yet been tested in combination with the AP of Inreda. Both are insulin lispro, but additions to the insulin lispro allow the insulin to act faster with a shorter duration. The hypothesis is that the combination of Lyumjev and the reactive AP system can decrease the time that glucose values are above range which can have a positive effect on glucose regulation.

Objectives of the study:

The main objective is to determine the efficacy of Lyumjev in the Inreda AP system. Secondary objectives are to assess safety parameters, differences in pharmacodynamics and AP-related outcomes comparing Lyumjev to Humalog®.

Study design:

This study is a multicenter, open-label, randomized, cross-over trial which will be performed in a free-living environment.

Study population:

The study population will comprise 12 subjects with diabetes type 1 using the AP system. Inclusion criteria are subjects from 18 to 75 years and treated with the Inreda AP system for at least 1 month.

Intervention:

The intervention includes the administration of Lyumjev by the Inreda AP system. The subject will be randomized to receive either Lyumjev or Humalog® during the first 30 days. After a wash-out period of 8 days using the standard insulin Humalog®, the subject will switch to the alternate treatment, again for a 30-day period. During the study periods, subjects have to keep a Wi-Fi access point with them.

Primary study parameters/outcome of the study:

Main parameter to express efficacy is the time above range (>10.0 mmol/l), which will be compared between Lyumjev and Humalog®.

Secondary study parameters/outcome of the study:

Safety will be expressed as the side effects of Lyumjev. Pharmacodynamics will be expressed in proportions of time spent in eu-/hypo-/hyperglycemia (%), median glucose value (mmol/l) and glycemic variability (% and interquartile range). These parameters will all be compared between Lyumjev and reference Humalog®.

AP-related outcomes will be expressed in daily administered dosage of insulin and glucagon (units), and the percentage of time that the closed loop algorithm is active (%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 16, 2023
• Est. primary completion date: March 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Since subjects are treated with the Inreda AP, the following inclusion criteria will be met:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Insulin Lispro Cartridge [Lyumjev]
Administration of Lyumjev in combination with the AP system
• Insulin Lispro Cartridge
Administration of Humalog in combination with the AP system (standard therapy)

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland
Netherlands	Slingeland Hospital	Doetinchem	Gelderland
Netherlands	Hospital Gelderse Vallei	Ede	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Inreda Diabetic B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time the glucose level is above 10 mmol/l for the study participants	Time the glucose level is above range (>10 mmol/l) expressed as a percentage (%)	68 days
Secondary	Safety parameters	Side effects of Lyumjev	30 days
Secondary	Pharmacodynamic parameters: euglycemia	Percentage of time the glucose level is between 3.9 and 10 mmol/l (%)	68 days
Secondary	Pharmacodynamic parameters: hypoglycemia	Percentage of time the glucose level is below 3.9 mmol/l (%)	68 days
Secondary	Pharmacodynamic parameters: median glucose value	Median of the glucose values (mmol/l)	68 days
Secondary	Pharmacodynamic parameters: standard deviation of glucose value	Standard deviation of the glucose values (parameter required to determine the coefficient of variation)	68 days
Secondary	Pharmacodynamic parameters: mean glucose value	Mean of the glucose values (parameter required to determine the coefficient of variation)	68 days
Secondary	Pharmacodynamic parameters: glycemic variability (CoV)	Glycemic variability expressed as the coefficient of variation (CoV): standard deviation divided by the mean of the glucose values (%)	68 days
Secondary	Pharmacodynamic parameters: glycemic variability (IQR)	Glycemic variability expressed as the interquartile range (IQR) (mmol/l)	68 days
Secondary	AP-related parameters: insulin usage	Daily usage of insulin (units)	68 days
Secondary	AP-related parameters: glucagon usage	Daily usage of glucagon (units)	68 days
Secondary	AP-related parameters: algorithm activity	Percentage of time the algorithm is active (%)	68 days