CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 375 enrolled
Drug / intervention
sliding scale regular insulin (SSRI) +2 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/NCT00979628
NCT00979628Phase 4Completed
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Basal Bolus Versus Basal Insulin Regimen for the Treatment of Hospitalized Patients With Type 2 Diabetes Mellitus

Guillermo Umpierrez, MD·interventional·Posted Sep 18, 2009·Updated Oct 10, 2018

In Brief

A Phase 4 clinical trial evaluating sliding scale regular insulin (SSRI), Basal Bolus, and 1 other intervention for Type 2 Diabetes and Hyperglycemia. Completed, enrolled 375 participants across 5 sites.

Detailed Summary

The study is a prospective randomized study comparing safety and effectiveness of a basal-bolus regimen with glargine once daily and glulisine before meals, a basal plus regimen with glargine once daily and supplemental doses of glulisine, and sliding scale regular insulin (SSI) on correction of insulin regimen for the hospital management of medical and surgical patients with type 2 diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes, Hyperglycemia
CountriesUnited States
CollaboratorsSanofi, Medical University of South Carolina, Texas A&M University

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 18, 2009
Enrollment StartJan 1, 2010
Primary CompletionMar 1, 2012
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 16.8 years ago

Interventions

sliding scale regular insulin (SSRI)drug

four-time daily in patients with T2DM admitted to general medicine and surgery wards.

Basal Bolusdrug

glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)

Basal Plusdrug

glargine once daily plus corrective doses of glulisine before meals and bedtime as needed