CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 130 enrolled
Drug / intervention
Detemir + aspart insulin before meals +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/NCT00590226
NCT00590226Phase 4Completed

Comparative Trial Between Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Type 2 Diabetes

Emory University·interventional·Posted Jan 10, 2008·Updated Jun 11, 2014

In Brief

A Phase 4 clinical trial evaluating Detemir + aspart insulin before meals and NPH insulin + regular insulin for Type 2 Diabetes. Completed, enrolled 130 participants across 2 sites.

Detailed Summary

High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. It is not known; however, what is the best insulin regimen in hospitalized patients. Recently, the use of basal/bolus insulin therapy with detemir (Levemir®) and rapid-acting insulin (lispro, aspart, glulisine) has been shown to facilitate outpatient glycemic control with lower rate of hypoglycemic (low blood sugar) events in patients with diabetes. In this study, we will determine the efficacy and safety of the combination of detemir and aspart insulin in the inpatient management of subjects with diabetes. We hypothesize that in patients with type 2 diabetes admitted to general medicine wards, treatment with insulin detemir once daily plus insulin aspart before meals will allow better glycemic control and lower rate of hypoglycemic events than treatment with twice a day NPH plus regular insulin before meals. Detemir is a long-acting insulin which is given subcutaneously (under the skin) once daily. Aspart is a rapid-acting insulin which is given subcutaneously several times a day and frequently before meals. Detemir and aspart insulins are approved for use in the treatment of patients with diabetes by the FDA. This investigator-initiated research will be conducted at Grady Memorial Hospital, Atlanta and at Rush University Medical Center, Chicago, IL. Dr. Umpierrez designed the study and will serve as principal investigator. A total of 65 patients will be recruited at Grady and 65 patients at the Rush University Medical Center, Chicago, IL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesUnited States
CollaboratorsNovo Nordisk A/S

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 10, 2008
Enrollment StartDec 1, 2006
Primary CompletionJan 1, 2008
Study CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.5 years ago

Interventions

Detemir + aspart insulin before mealsdrug

Detemir insulin SQ once daily + aspart insulin SQ before meals

NPH insulin + regular insulindrug

NPH insulin SQ + regular insulin SQ before breakfast and dinner