Clinical trial NCT05067270: A Study of Infusion Site Pain After Infusion of Excipients in Participants With Type 1 Diabetes Mellitus
Official title: A Study to Investigate Local Infusion Site Pain After Infusion of Excipients Across Infusion Sites and Infusion Depths
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes Mellitus
Keywords: Humalog - Insulin lispro
Citrate
Infusion Site Pain
Excipients
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-10-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate the effect of excipients sodium citrate and treprostinil without insulin on local infusion site pain in participants with type 1 diabetes mellitus (T1DM) on continuous subcutaneous insulin infusion (CSII). The study may last up to 36 days including a screening period and 3 visits.


Eligibility criteria: Inclusion Criteria:

* T1D for at least 1 year and continuously using insulin for at least 1 year
* Using an insulin pump for at least the last 6 months
* Have hemoglobin A1c (HbA1c) value of ≤ 9.0%
* Have a body mass index (BMI) within the range of 18.5 to 35.0 kilograms per square meter (kg/m²)
* Have medical and laboratory test results that are acceptable for the study
* Have venous access sufficient to allow for blood sampling

Exclusion Criteria:

* Hemophilia or any other bleeding disorder
* Have a pathologic tuning fork test as assessed with a Rydel-Seiffer tuning fork
* Are taking anesthetics or pain medication regularly or intermittently which could interfere with interpretation of pain scale
* Have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within the last 90 days prior to screening
* Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within the last 6 months prior to screening
* Have any hypersensitivity or allergy to any of the diluents or excipients used in this trial
* Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Have participated, within the last 30 days, in a clinical trial involving an investigational product
* Have used or are currently using Lyumjev® as part of their standard insulin therapy

Primary outcomes:
measure: Visual Analog Scale (VAS) Pain Score in the Abdominal, Arm, Thigh, and Buttock Areas
timeFrame: Day 1: 1 min post bolus.
Secondary outcomes:
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Profil Mainz
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Ignaut D, Fukuda T, Bandi R, Ermer M, Stoffel MS, Zijlstra E, Paavola C. An Investigation Into Local Infusion Site Pain After Infusion of Ultra Rapid Lispro Excipients Across Sites and Depths. J Diabetes Sci Technol. 2024 Jul;18(4):920-929. doi: 10.1177/19322968221135217. Epub 2022 Nov 3.