CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 420 enrolled
Drug / intervention
Human regular U-500 insulin (CSII) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02561078
NCT02561078Phase 3Completed
CompareCT.gov

Safety and Efficacy of Human Regular U-500 Insulin Administered by Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injections in Subjects With Type 2 Diabetes Mellitus: A Randomized, Open-Label, Parallel Clinical Trial

Eli Lilly and Company·interventional·Posted Sep 25, 2015·Updated May 20, 2020

In Brief

A Phase 3 clinical trial evaluating Human regular U-500 insulin (CSII) and Human regular U-500 insulin (MDI) for Type 2 Diabetes Mellitus. Completed, enrolled 420 participants across 57 sites in 2 countries.

Detailed Summary

The main purpose of this study is to evaluate the efficacy and safety of the study drug known as human regular U-500 insulin (U-500R) administered by continuous subcutaneous insulin infusion (CSII) versus multiple daily injections (MDI) in participants with type 2 diabetes mellitus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesPuerto Rico, United States
CollaboratorsInsulet Corporation

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 25, 2015
Enrollment StartOct 20, 2015
Primary CompletionMay 9, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.8 years ago

Interventions

Human regular U-500 insulin (CSII)drug

Administered SC

Human regular U-500 insulin (MDI)drug

Administered SC