CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 114 enrolled
Drug / intervention
0.5 units/kg daily insulin +1 moredrug
Likely dose
0.5 units/kg daily insulinfrom 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/NCT00911625
NCT00911625Phase 4Completed
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Glargine Dosing in Hospitalized Patients With Type 2 Diabetes and Renal Insufficiency

Loyola University·interventional·Posted Jun 2, 2009·Updated Apr 6, 2017

In Brief

A Phase 4 clinical trial evaluating 0.5 units/kg daily insulin and 0.25 units/kg daily insulin for Type 2 Diabetes and Renal Insufficiency. Completed, enrolled 114 participants across 3 sites.

Detailed Summary

It is imperative to devise easy to follow, yet appropriate, guidelines for insulin use in renal-impaired patients. This will be done by comparing two regimens: 1) glargine once daily plus mealtime glulisine based on weight alone and 2) a predetermined dosing reduction algorithm with glargine/glulisine based on weight with reduction for decreased estimated GFR by MDRD as follows: \< 30 ml/min/1.73m2 or on dialysis reduce dose by 50% from weight based calculation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes, Renal Insufficiency
CountriesUnited States
CollaboratorsSanofi

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2, 2009
Enrollment StartJan 21, 2009
Primary CompletionJun 30, 2011
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 17.1 years ago

Interventions

0.5 units/kg daily insulindrug

Participants randomized to receive this intervention will receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine.

0.25 units/kg daily insulindrug

Participants randomized to receive this intervention will receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine.