UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041001 |
|---|---|
| Receipt number | R000046816 |
| Scientific Title | Perioperative glycemic control with insulin glargine 300 U/mL versus insulin degludec for surgical patients with type 2 diabetes in non-intensive care unit |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2024/02/13 13:53:19 |
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Basic information
Public title
Perioperative glycemic control with insulin glargine 300 U/mL versus insulin degludec for surgical patients with type 2 diabetes in non-intensive care unit
Acronym
PREMIER-INSULIN study
Scientific Title
Perioperative glycemic control with insulin glargine 300 U/mL versus insulin degludec for surgical patients with type 2 diabetes in non-intensive care unit
Scientific Title:Acronym
PREMIER-INSULIN study
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify optimal long-acting insulin for perioperative blood glucose control.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean postoperative blood glucose levels(Mean blood glucose levels from 1 day to 3 days after surgery)
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The groups using insulin glargine U-300
Interventions/Control_2
The groups using insulin degludec
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Sugihara |
Organization
Graduate School of Medicine, Nippon Medical School
Division name
Department of Endocrinology, Diabetes and Metabolism
Zip code
113-8602
Address
1-1-5, sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
03-5814-6267
hitoshi@nms.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Oba |
Organization
Graduate School of Medicine, Nippon Medical School
Division name
Department of Endocrinology, Diabetes and Metabolism
Zip code
113-8602
Address
1-1-5, sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
03-5814-6267
Homepage URL
t-ooba@nms.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Medicine, Nippon Medical School
Address
1-1-5, sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
Tel
03-5802-8667
officetokutei@nms.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 04 | Day |
Last modified on
| 2024 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046816
