A Study of Infusion Site Pain After Infusion of Excipients in Participants With Type 1 Diabetes Mellitus

Type 1 Diabetes Mellitus Clinical Trial

Official title:

A Study to Investigate Local Infusion Site Pain After Infusion of Excipients Across Infusion Sites and Infusion Depths

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05067270
• Other study ID #: 18278
• Secondary ID: I8B-MC-ITTC2021-
• Status: Completed
• Phase: Phase 1
• Start date: October 22, 2021
• Est. completion date: December 6, 2021

Study information

• Verified date: December 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 6, 2021
• Est. primary completion date: December 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Sodium Citrate
Administered SC infusion.
• Treprostinil
Administered SC infusion.
• Humalog diluent
Administered SC infusion.
• Magnesium Chloride
Administered SC infusion.

Locations

Country	Name	City	State
Germany	Profil Mainz	Mainz
Germany	Profil Institut für Stoffwechselforschung	Neuss	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS) Pain Score in the Abdominal, Arm, Thigh, and Buttock Areas	The Infusion site pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst imaginable pain).	Day 1: 1 min post bolus.