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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name