| Trial ID: | L5562 |
| Source ID: | NCT05067270
|
| Associated Drug: |
Sodium Citrate
|
| Title: |
A Study of Infusion Site Pain After Infusion of Excipients in Participants With Type 1 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT05067270/results
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: Sodium Citrate|DRUG: Treprostinil|DRUG: Humalog diluent|DRUG: Magnesium Chloride
|
| Outcome Measures: |
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. |
|
| Sponsor/Collaborators: |
Sponsor: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2021-10-22
|
| Completion Date: |
2021-12-06
|
| Results First Posted: |
2023-10-04
|
| Last Update Posted: |
2023-10-04
|
| Locations: |
Profil Institut für Stoffwechselforschung, Neuss, Nordrhein-Westfalen, 41460, Germany|Profil Mainz, Mainz, 55116, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT05067270
|
