CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 402 enrolled
Drug / intervention
Lantus +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/NCT00309465
NCT00309465Phase 4Completed
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A Study of the Relationship Between the Proportional Insulin Glargine Evening Dose and the Perioperative Serum Glucose Values in Patients With Diabetes Undergoing Surgery

Tamra Dukatz·interventional·Posted Mar 31, 2006·Updated Dec 3, 2012

In Brief

A Phase 4 clinical trial evaluating Lantus and Insulin for Diabetes and Surgery. Completed, enrolled 402 participants across 2 sites.

Detailed Summary

The main objective of this study is to compare three strategies of evening insulin glargine dosing to preoperative glucose values in patients with diabetes undergoing surgery to determine which dosing strategies most often achieves the admission target study values of 100-179 mg/dl.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Surgery
CountriesUnited States
CollaboratorsSanofi

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 31, 2006
Enrollment StartOct 1, 2005
Primary CompletionOct 1, 2008
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.3 years ago

Interventions

Lantusdrug

Patients in Group 1 will administer 80% of their usual insulin glargine dose.

Insulinother

Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose

Lantusdrug

Group 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. Which of those three percentages will be determined by the midpoint of the patient's usual self-reported fasting blood sugar (FBS) range and whether the patients is also taking a rapid-acting insulin.