CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
Sodium Citrate +3 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Type 1 Diabetes for at least 1 year with continuous insulin use for at least 1 year
  • ✓Using an insulin pump for at least the last 6 months
  • ✓HbA1c ≤9.0%
  • ✓BMI 18.5–35.0 kg/m²
Key exclusion· 8
  • ✕Hemophilia or any bleeding disorder
  • ✕Abnormal tuning fork test (Rydel-Seiffer) indicating neuropathy
  • ✕Regular or intermittent use of anesthetics or pain medication that could interfere with pain assessment
  • ✕More than 1 episode of severe hypoglycemia requiring assistance within the last 90 days

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05067270
NCT05067270Phase 1Completed
CompareCT.gov

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

Eli Lilly and Company·interventional·Posted Oct 5, 2021·Updated Oct 4, 2023

In Brief

A Phase 1 clinical trial evaluating Sodium Citrate, Treprostinil, and 2 other interventions for Type 1 Diabetes Mellitus. Completed, enrolled 40 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedOct 5, 2021
Enrollment StartOct 22, 2021
Primary CompletionDec 6, 2021
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 4.7 years ago

Interventions

Sodium Citratedrug

Administered SC infusion.

Treprostinildrug

Administered SC infusion.

Humalog diluentdrug

Administered SC infusion.

Magnesium Chloridedrug

Administered SC infusion.