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NCT05067270

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

A Study to Investigate Local Infusion Site Pain After Infusion of Excipients Across Infusion Sites and Infusion Depths
Eli Lilly and Company·Phase 1·ClinicalTrials.gov·drugCompleted
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Type 1 Diabetes Mellitus
Drug/Device/Intervention
Sodium Citrate
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Eli Lilly and Company
Location
Neuss,Mainz, Germany
Timeline & enrollment
Phase
Phase 1
Start date
Oct 22, 2021
End date
Dec 06, 2021
Enrollment
40 participants
Primary outcome

Visual Analog Scale (VAS) Pain Score

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.

ICD-10 classifications
Type 1 diabetes mellitusType 1 diabetes mellitus with unspecified complicationsType 1 diabetes mellitus with other specified complicationsType 1 diabetes mellitus without complicationsType 1 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05067270
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05067270 through Pure Global AI's free database. This Phase 1 trial is sponsored by Eli Lilly and Company and is currently Completed. The study focuses on Type 1 Diabetes Mellitus. Target enrollment is 40 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.