Perioperative glycemic control with insulin glargine 300 U/mL versus insulin degludec for surgical patients with type 2 diabetes in non-intensive care unit

Not Applicable

Recruiting

• Conditions: type 2 diabetes

• Registration Number: JPRN-UMIN000041001
• Lead Sponsor: Graduate School of Medicine, Nippon Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-01
• Study Completion: 2023-07-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Patients who have at least one of the following are excluded from the study. 1. Patients who are discharged from the hospital the day after surgery (for example, patients who undergo prostate biopsy or cataract surgery) 2.Patients who are using preoperative steroids or who are scheduled to use steroids during and after surgery. 3. Patients with or suspected of having active infection 4. Patients with diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome. 5. Patients with or suspected of being allergic to insulin glargine U-300 or insulin degludec 6. Pregnant women or women who may be pregnant, or breast-feeding patients 7. Patients who participated in another clinical study within 4 months before the start of the study. 8. Patients who are judged to be unsuitable for participation in this study by the investigator or the subinvestigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean postoperative blood glucose levels(Mean blood glucose levels from 1 day to 3 days after surgery)

Secondary Outcome Measures

Name	Time	Method
Mean preoperative blood glucose levels Standard deviation of preoperative blood glucose levels Preoperative blood glucose coefficient of variation Immediate preoperative blood glucose levels Mean blood glucose levels on the day of surgery Standard deviation of postoperative blood glucose levels Postoperative blood glucose coefficient of variation Mean perioperative blood glucose levels Standard deviation of perioperative blood glucose levels Perioperative blood glucose coefficient of variation Incidence of postoperative complications Incidence of perioperative hypoglycemia Incidence of perioperative severe hypoglycemia Perioperative adverse event rate