CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 120 enrolled
Drug / intervention
NPH/Regular 70/30 mix +1 moredrug
Likely dose
NPH/Regular 70/30 mix 0.5 unitsfrom 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/NCT00821795
NCT00821795Phase 4Completed

Veterans Inpatient Insulin Study and Transition Algorithm: Efficacy of Insulin Analogs for Inpatient Glycemic Control and Transition to Outpatient Therapy

Dennis G. Karounos, M.D.·interventional·Posted Jan 13, 2009·Updated Mar 4, 2020

In Brief

A Phase 4 clinical trial evaluating NPH/Regular 70/30 mix and insulin aspart protamine/insulin aspart 70/30 mix for Type 2 Diabetes Mellitus. Completed, enrolled 120 participants across 1 site.

Detailed Summary

Volunteers are being invited to take part in a research study about insulin therapy of diabetes. They are being invited to take part in this research study because they have diabetes and have an illness requiring hospitalization. If they volunteer to take part in this study, they will be one of about 120 people to do so. The investigators hope to answer the following research questions: * To show that insulin aspart protamine 70/30 mix taken twice daily is as good as insulin NPH/Reg 70/30 mix taken twice a day for treatment of diabetes after discharge from the hospital. * To show how safe the two medicines are (insulin aspart 70/30 mix vs. insulin NPH/Reg 70/30 mix) and how well they work for the treatment of diabetes when transitioning from inpatient therapy to outpatient care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsNovo Nordisk A/S

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 13, 2009
Enrollment StartMar 11, 2009
Primary CompletionApr 23, 2013
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 17.5 years ago

Interventions

NPH/Regular 70/30 mixdrug

injectable solution, subcutaneous,0.3-0.5 units/kg/day divided into twice per day dosage, 16 weeks duration

insulin aspart protamine/insulin aspart 70/30 mixdrug

injectable solution, subcutaneous, 0.3-0.5 units/kg/day divided into twice per day dosage, for 16 weeks