At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Randomized, Crossover Trial of CSII Reservoir In-use Comparing Insulin Lispro Formulation to Insulin Aspart in Patients With Type 1 Diabetes Mellitus
In Brief
A Phase 3 clinical trial evaluating Insulin lispro 2 day reservoir in-use, Insulin lispro 6 day reservoir in-use, and 1 other intervention for Diabetes Mellitus, Type 1. Completed, enrolled 132 participants across 11 sites.
Detailed Summary
This is a 6-sequence, 3-period (8 weeks each), 3-arm, 24-week crossover study. The purpose of this study is to provide information on the use of insulin lispro in insulin pumps (Continuous Subcutaneous Insulin Infusion \[CSII\]) compared to insulin aspart over 6 days of pump reservoir in-use. The study will also compare the in-use characteristics of insulin lispro infused at 6 days with insulin lispro infused at 2 days.
Study Details
Timeline
Interventions
Insulin lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
Insulin lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period.
Insulin aspart 6 Day (A6D) administered by infusion pump for 8 week treatment period.