CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 21 enrolled
Drug / intervention
U-500 Insulin delivered by Omnipod (disposable insulin pump)drug
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/NCT00606034
NCT00606034Phase 4Completed
CompareCT.gov

A Prospective Trial of U500 Regular Insulin by Continuous Subcutaneous Insulin Infusion in Patients With Type 2 Diabetes and Severe Insulin Resistance Who Have Failed Previous Insulin Regimens

Mountain Diabetes and Endocrine Center·interventional·Posted Feb 1, 2008·Updated Feb 6, 2014

In Brief

A Phase 4 clinical trial evaluating U-500 Insulin delivered by Omnipod (disposable insulin pump) for Type 2 Diabetes and Insulin Resistance. Completed, enrolled 21 participants across 1 site.

Detailed Summary

Patients with Type 2 diabetes and severe insulin resistance with very large insulin requirements who have failed all previous insulin regimens using non-concentrated forms of insulin (U100 insulin formulations) will receive 5X concentrated insulin (U500 regular insulin)infused via insulin pump.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes, Insulin Resistance
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 1, 2008
Enrollment StartDec 1, 2007
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.4 years ago

Interventions

U-500 Insulin delivered by Omnipod (disposable insulin pump)drug

U-500 insulin (concentrated insulin) will be infused continuously subcutaneously using a disposable insulin pump called an Omnipod; the insulin infusion dosage will be individualized to each subject's needs