UMIN-CTR Clinical Trial

Basic information
Public title	Safety and Efficacy of dulaglutide therapy for perioperative glycaemic control
Acronym	Safety and Efficacy of dulaglutide therapy for perioperative glycaemic control
Scientific Title	Safety and Efficacy of dulaglutide therapy for perioperative glycaemic control
Scientific Title:Acronym	Safety and Efficacy of dulaglutide therapy for perioperative glycaemic control
Region	Japan

Condition
Condition	type2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study investgates the safety and efficacy of dulaglutide therapy for perioperative glycaemic control
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Data of CGM pre-operation,post-operation,day1,day2
Key secondary outcomes

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	Dulaglutide plus basal insulin group: this group receives dulaglutide once weekly with basal insulin once daily and supplemental dose of regular insulin. Study term is total 8days, 4days before operation to 3days after operation.
Interventions/Control_2	Basal insulin group: this group receives basal insulin once daily and supplermental dose of regular insulin during study term.
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	15 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with type 2 diabetes who need perioperative glycaemic control
Key exclusion criteria	Patients admitted to or expected to require ICU admission or cardiac surgery or abdminal surgery; patients with a history of pancreatitis or corticosteroid therapy, clinically relevant hepatic disease,or impaired renal function (serum creatinine >3.0 mg/dL); and patients with a history of diabetic ketoacidosis, pregnancy, or any mental condition rendering the subject unable to give informed consent.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nobutoshi Fushimi
Organization	Ichinomiyanishi Hospital
Division name	Department of Endocrinology and Diabetes
Zip code
Address	1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, JAPAN
TEL	0586-48-0077
Email	nobutoshi243@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Nobutoshi Fushimi
Organization	Ichinomiyanishi hospital
Division name	Department of Endocrinology and Diabetes
Zip code
Address	1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, JAPAN
TEL	0586-48-0077
Homepage URL
Email	nobutoshi243@yahoo.co.jp

Sponsor
Institute	Ichinomiyanishi hospital
Institute
Department

Funding Source
Organization	nothing
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2017 Year 04 Month 05 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	Terminated
Date of protocol fixation	2016 Year 10 Month 01 Day
Date of IRB	2016 Year 10 Month 01 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date	2022 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 10 Month 08 Day
Last modified on	2022 Year 02 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026748