- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05067270
A Study of Infusion Site Pain After Infusion of Excipients in Participants With Type 1 Diabetes Mellitus
December 4, 2022 updated by: Eli Lilly and Company
A Study to Investigate Local Infusion Site Pain After Infusion of Excipients Across Infusion Sites and Infusion Depths
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Mainz, Germany, 55116
- Profil Mainz
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Nordrhein-Westfalen
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Neuss, Nordrhein-Westfalen, Germany, 41460
- Profil Institut für Stoffwechselforschung
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 67 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sequence 1:Arm Region,Abdomen 6mm,Buttock,Abdomen 9mm,Thigh
Participants had cannulas inserted into each of the designated infusion sites (6 millimeter (mm) for all the sites.
Additionally for the abdominal area only, a 9 mm cannula was also inserted into the opposite side of the lower abdomen), and the first infusion site was initiated subcutaneously (SC) with 15 millimolar (mM) sodium citrate and 1 microgram per milliliter (μg/mL) treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution at a basal infusion rate of 1 unit per hour (U/h).
The same procedure occurred at subsequent infusion sites with an approximately 30-minute (min) interval between each initiation.
Approximately 3, 6, and 9 hours after the start of the basal infusion, a bolus dose of 15 U was delivered at quick bolus speed (15 U/min) to each infusion site according to the treatment sequence with an approximately 30-minute interval between infusion sites.
|
Administered SC infusion.
Administered SC infusion.
Administered SC infusion.
Administered SC infusion.
|
Experimental: Sequence 2:Abdomen 6mm,Abdomen 9mm,Arm Region,Thigh,Buttock
Participants had cannulas inserted into each of the designated infusion sites (6 mm for all the sites.
Additionally for the abdominal area only, a 9 mm cannula was also inserted into the opposite side of the lower abdomen), and the first infusion site was initiated with 15 mM sodium citrate and 1 μg/mL treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution at a basal infusion rate of 1 U/h.
The same procedure occurred at subsequent infusion sites with an approximately 30-minute interval between each initiation.
Approximately 3, 6, and 9 hours after the start of the basal infusion, a bolus dose of 15 U was delivered at quick bolus speed (15 U/min) to each infusion site according to the treatment sequence with an approximately 30-minute interval between infusion sites.
|
Administered SC infusion.
Administered SC infusion.
Administered SC infusion.
Administered SC infusion.
|
Experimental: Sequence 3:Abdomen 9mm,Thigh,Abdomen 6mm,Buttock,Arm Region
Participants had cannulas inserted into each of the designated infusion sites (6 mm for all the sites.
Additionally for the abdominal area only, a 9 mm cannula was also inserted into the opposite side of the lower abdomen), and the first infusion site was initiated with 15 mM sodium citrate and 1 μg/mL treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution at a basal infusion rate of 1 U/h.
The same procedure occurred at subsequent infusion sites with an approximately 30-minute interval between each initiation.
Approximately 3, 6, and 9 hours after the start of the basal infusion, a bolus dose of 15 U was delivered at quick bolus speed (15 U/min) to each infusion site according to the treatment sequence with an approximately 30-minute interval between infusion sites.
|
Administered SC infusion.
Administered SC infusion.
Administered SC infusion.
Administered SC infusion.
|
Experimental: Sequence 4:Thigh,Buttock,Abdomen 9mm,Arm Region,Abdomen 6mm
Participants had cannulas inserted into each of the designated infusion sites (6 mm for all the sites.
Additionally for the abdominal area only, a 9 mm cannula was also inserted into the opposite side of the lower abdomen), and the first infusion site was initiated with 15 mM sodium citrate and 1 μg/mL treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution at a basal infusion rate of 1 units per U/h.
The same procedure occurred at subsequent infusion sites with an approximately 30-minute interval between each initiation.
Approximately 3, 6, and 9 hours after the start of the basal infusion, a bolus dose of 15 U was delivered at quick bolus speed (15 U/min) to each infusion site according to the treatment sequence with an approximately 30-minute interval between infusion sites.
|
Administered SC infusion.
Administered SC infusion.
Administered SC infusion.
Administered SC infusion.
|
Experimental: Sequence 5:Buttock,Arm Region,Thigh,Abdomen 6mm,Abdomen 9mm
Participants had cannulas inserted into each of the designated infusion sites (6 mm for all the sites.
Additionally for the abdominal area only, a 9 mm cannula was also inserted into the opposite side of the lower abdomen), and the first infusion site was initiated with 15 mM sodium citrate and 1 μg/mL treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution at a basal infusion rate of 1 U/h.
The same procedure occurred at subsequent infusion sites with an approximately 30-minute interval between each initiation.
Approximately 3, 6, and 9 hours after the start of the basal infusion, a bolus dose of 15 U was delivered at quick bolus speed (15 U/min) to each infusion site according to the treatment sequence with an approximately 30-minute interval between infusion sites.
|
Administered SC infusion.
Administered SC infusion.
Administered SC infusion.
Administered SC infusion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS) Pain Score in the Abdominal, Arm, Thigh, and Buttock Areas
Time Frame: Day 1: 1 min post bolus.
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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).
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Day 1: 1 min post bolus.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: 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), Eli Lilly and Company
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 22, 2021
Primary Completion (Actual)
December 6, 2021
Study Completion (Actual)
December 6, 2021
Study Registration Dates
First Submitted
September 28, 2021
First Submitted That Met QC Criteria
September 28, 2021
First Posted (Actual)
October 5, 2021
Study Record Updates
Last Update Posted (Actual)
October 4, 2023
Last Update Submitted That Met QC Criteria
December 4, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Anticoagulants
- Chelating Agents
- Sequestering Agents
- Calcium Chelating Agents
- Insulin Lispro
- Citric Acid
- Sodium Citrate
- Treprostinil
Other Study ID Numbers
- 18278
- I8B-MC-ITTC (Other Identifier: Eli Lilly and Company)
- 2021-001987-18 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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