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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041001
Enrollment
180
Registered
2020-08-01
Start date
2020-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes

Interventions

The groups using insulin glargine U-300 The groups using insulin degludec

Sponsors

Graduate School of Medicine, Nippon Medical School
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following conditions are included in this study. 1. Men and women who are 20 years or older at the time of obtaining consent. 2. Patients who use or are more likely to use long-acting insulin in the perioperative period. 3.Patients who are hospitalized 3 days before surgery or more. 4.Patients who can agree to participate in the study subject's free will and can comply with this implementation plan.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Mean postoperative blood glucose levels(Mean blood glucose levels from 1 day to 3 days after surgery)

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactTakeshi Oba

Graduate School of Medicine, Nippon Medical School Department of Endocrinology, Diabetes and Metabolism

t-ooba@nms.ac.jp03-5814-6267

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026