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NCT Number: NCT05067270

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung, Neuss, North Rhine-Westphalia, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sodium citrate

Drug

Administered SC infusion.

Treprostinil

Drug

Administered SC infusion.

Humalog diluent

Drug

Administered SC infusion.

Magnesium Chloride

Drug

Administered SC infusion.

Primary outcomes

  1. Visual Analog Scale (VAS) Pain Score in the Abdominal, Arm, Thigh, and Buttock Areas

    Time frame: Day 1: 1 min post bolus.

    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).

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 5, 2021
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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