drugset / Trial / NCT00309465

Perioperative Insulin Glargine Dosing Study

NCT00309465 ↗

Phase 4 Completed 402 enrolled Tamra Dukatz Sanofi · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2005-10
Primary completion
2008-10
Completion
2009-10

Outcome

Mixed primary results

registry p = 0.031; Chi-squared; note: P value is for three strategies in insulin glargine plus bolus group NCT00309465 ↗

registry NUMBER Dose Table (Insulin Glargine Plus Bolus Group): Achievement of 80-249 mg/dl: 93.4 Percentage of subjects NCT00309465 ↗

registry p = 0.332; Chi-squared; note: P-value for three dosing strategies in insulin glargine only group NCT00309465 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin glargine Protein / enzyme biologic 50 % —
Subject insulin glargine Protein / enzyme biologic 80 % —
Subject insulin glargine Protein / enzyme biologic 100 % —

Indications