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Clinical trial

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

ID
Name
18278
Description
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.
Trial arms
Trial start
2021-10-22
Estimated PCD
2021-12-06
Trial end
2021-12-06
Status
Completed
Phase
Early phase I
Treatment
Sodium Citrate
Administered SC infusion.
Arms:
Sequence 1:Arm Region,Abdomen 6mm,Buttock,Abdomen 9mm,Thigh, Sequence 2:Abdomen 6mm,Abdomen 9mm,Arm Region,Thigh,Buttock, Sequence 3:Abdomen 9mm,Thigh,Abdomen 6mm,Buttock,Arm Region, Sequence 4:Thigh,Buttock,Abdomen 9mm,Arm Region,Abdomen 6mm, Sequence 5:Buttock,Arm Region,Thigh,Abdomen 6mm,Abdomen 9mm
Treprostinil
Administered SC infusion.
Arms:
Sequence 1:Arm Region,Abdomen 6mm,Buttock,Abdomen 9mm,Thigh, Sequence 2:Abdomen 6mm,Abdomen 9mm,Arm Region,Thigh,Buttock, Sequence 3:Abdomen 9mm,Thigh,Abdomen 6mm,Buttock,Arm Region, Sequence 4:Thigh,Buttock,Abdomen 9mm,Arm Region,Abdomen 6mm, Sequence 5:Buttock,Arm Region,Thigh,Abdomen 6mm,Abdomen 9mm
Humalog diluent
Administered SC infusion.
Arms:
Sequence 1:Arm Region,Abdomen 6mm,Buttock,Abdomen 9mm,Thigh, Sequence 2:Abdomen 6mm,Abdomen 9mm,Arm Region,Thigh,Buttock, Sequence 3:Abdomen 9mm,Thigh,Abdomen 6mm,Buttock,Arm Region, Sequence 4:Thigh,Buttock,Abdomen 9mm,Arm Region,Abdomen 6mm, Sequence 5:Buttock,Arm Region,Thigh,Abdomen 6mm,Abdomen 9mm
Magnesium Chloride
Administered SC infusion.
Arms:
Sequence 1:Arm Region,Abdomen 6mm,Buttock,Abdomen 9mm,Thigh, Sequence 2:Abdomen 6mm,Abdomen 9mm,Arm Region,Thigh,Buttock, Sequence 3:Abdomen 9mm,Thigh,Abdomen 6mm,Buttock,Arm Region, Sequence 4:Thigh,Buttock,Abdomen 9mm,Arm Region,Abdomen 6mm, Sequence 5:Buttock,Arm Region,Thigh,Abdomen 6mm,Abdomen 9mm
Size
40
Primary endpoint
Visual Analog Scale (VAS) Pain Score in the Abdominal, Arm, Thigh, and Buttock Areas
Day 1: 1 min post bolus.
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2023-10-04

1 organization

4 products

1 indication

Organization
Eli Lilly and Company
Product
Treprostinil
Indication
Type 1 Diabetes Mellitus
Product
Sodium Citrate
Product
Humalog
Product
Magnesium Chloride