The main objective is to determine the efficacy of Lyumjev in the Inreda AP system. Secondary objectives are: to assess safety, differences in pharmacodynamics and differences in AP-related outcome measures.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main parameter to express efficacy is the time above range (>10 mmol/l), which
will be compared between Lyumjev and Humalog.
Secondary outcome
Safety parameters
- Side effects of Lyumjev
Pharmacodynamic parameters
- Percentage of time spent in range (3.9-10.0 mmol/l)
- Percentage of time spent below range (< 3.9 mmol/l)
- Percentage of time spent in level 2 below range (< 3.0 mmol/l)
- Percentage of time spent in level 2 above range (> 13.9 mmol/l)
- Mean/median glucose value
- Glycemic variability expressed as coefficient of variation (CV) and
interquartile range (IQR)
AP-related parameters
- Daily administered dosage of glucagon
- Daily administered dosage of insulin
- The percentage of time that the closed loop algorithm is active
Background summary
Inreda Diabetic B.V. (Goor, The Netherlands) developed a bihormonal reactive
closed loop system to automate glucose regulation (artificial pancreas; AP) in
patients with diabetes mellitus. In the current CE-marked AP, Humalog (Eli
Lilly) is used as insulin which is a rapid acting insulin lispro. Lyumjev (Eli
Lilly) also consists of insulin lispro but is ultra-rapid acting due to the
addition of 2 excipients. Therefore, Lyumjev is faster acting compared to
Humalog. Using Lyumjev instead of Humalog insulin could therefore result in
better glycemic control.
Study objective
The main objective is to determine the efficacy of Lyumjev in the Inreda AP
system. Secondary objectives are: to assess safety, differences in
pharmacodynamics and differences in AP-related outcome measures.
Study design
This study is a multicenter, open-labeled, randomized, cross-over trial.
Intervention
The intervention entails use of Lyumjev administered by the Inreda AP system.
The subjects will be randomized to receive either Lyumjev or Humalog during the
first study period of thirty days. After a wash-out period of eight days, the
subject will be switched to the alternate treatment according to randomization.
During both study periods subjects are asked to keep a WiFi access point with
them.
Study burden and risks
There are no major risks associated with this study, since the subjects will
use their usual kind of diabetes therapy, in which only the type of insulin is
adjusted for thirty days. The most prominent risk is potential altered
effectiveness of Lyumjev compared to the currently used insulin, which could
lead to hypo- and hyperglycemia, but high and low glucose values will be
indicated by alarms given by the Inreda AP system. The burden of the study is
relatively low. Subjects are not required to visit the CRC and the only
additional burden for participants is to keep a WiFi access point with them
during both study periods.
Klavermaten 65-5
Goor 7472 DD
NL
Klavermaten 65-5
Goor 7472 DD
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed with type 1 diabetes
- Treated with the Inreda Artificial Pancreas for a minimum of 1 month
- Age between 18 and 75 years
- Willing and able to sign informed consent
Exclusion criteria
- Impaired awareness of hypoglycemia (score >= 4) according to the Gold and/or
Clarke questionnaire
- Pregnancy and/or breastfeeding
- Use of oral antidiabetic agents
- Insulinoma
- Hypersensitivity reactions to Lyumjev insulin or any of the excipients
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2022-001373-31-NL |
| CCMO | NL79588.091.22 |