Phase 4 Completed N=402 Randomized Treatment

Perioperative Insulin Glargine Dosing Study

Diabetes · Surgery

Source: ClinicalTrials.gov NCT00309465 ↗

Enrolled (actual)

402

Serious AEs

0.3%

Results posted

Dec 2012

Primary outcomePrimary: Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery — 58.6; 72.4; 74.1; 58.7 Percentage of subjects — p=0.332

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery	58.6; 72.4; 74.1; 58.7; 52.6; 63.2	0.332

Eligibility Criteria

Inclusion Criteria

Scheduled for Surgical Procedure
Self Management of Diabetes
Currently on Evening Insulin Glargine prescribed by Primary Care Physician
Age 18 or over
Able to Communicate Clearly over the Phone
Pre-screened by Anesthesia Department > 48 hours prior to Surgery

Exclusion Criteria

On Glucocorticoid Medication
On Insulin Glargine Dual Dosing or Sliding Scale Regimen
History of Hypoglycemia Unawareness
Pregnancy or Lactating Female
On Insulin Glargine for < 3 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00309465). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.