Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05508061 |
| Other study ID # |
NL79588.091.22 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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 (%).
