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

Phase 1 Completed 40 enrolled Eli Lilly and Company

RandomizedCrossoverDouble-blindBasic science

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.

Timeline

Start: 2021-10-22
Primary completion: 2021-12-06
Completion: 2021-12-06

Publications

Ignaut D, Fukuda T, Bandi R, Ermer M, Stoffel MS, Zijlstra E, Paavola C. An Investigation Into Local Infusion Site Pain After Infusion of Ultra Rapid Lispro Excipients Across Sites and Depths. J Diabetes Sci Technol. 2024 Jul;18(4):920-929. doi: 10.1177/19322968221135217. Epub 2022 Nov 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Treprostinil	Other / unclassified	1 ug/ml	Subcutaneous
Subject	sodium citrate	Unknown	15 mmol	Subcutaneous
Background	MAGNESIUM CHLORIDE ANHYDROUS	Small molecule	5 mmol	Subcutaneous

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

Summary

Timeline

Publications

Drugs

Indications