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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041001
Receipt No. 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 2020/08/17

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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
Email 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
Email t-ooba@nms.ac.jp

Sponsor
Institute Graduate School of Medicine, Nippon Medical School
Institute
Department

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
Email 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
2020 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046816

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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