UMIN-CTR Clinical Trial

Basic information
Public title	A clinical trial of introduction and adjustment of insulin Degludec in hospitalized patients with type 2 diabetes
Acronym	TIAD study
Scientific Title	A clinical trial of introduction and adjustment of insulin Degludec in hospitalized patients with type 2 diabetes
Scientific Title:Acronym	TIAD study
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine safety and a harmful phenomenon (hypoglycemia, extension of the length of stay) when we use insulin degludec in hospitalized patient with type 2 diabetes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The days before fasting blood glucose achieving aim blood sugar level (126 mg/dl or less), ratio less than 70 mg/dl of sensor glucose levels, hypoglycemia frequency.
Key secondary outcomes	The hospitalization days, ratio of before less than 70-140 mg/dl of sensor glucose levels in the discharge day , correlation with the main end-point and patient background

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	We use insulin Degludec and insulin Aspart based on an algorithm during length of stay (approximately around 2 weeks) .
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The hospitalized patient because of poor blood sugar and was judged when basal-bolus insulin treatment was necessary
Key exclusion criteria	1)The patient that an agreement to participate in this examination is not provided 2)The patient who needs emergency for treatment including the diabetic ketoacidosis 3)The patient whom diabetic retinopathy is unstable 4)The patient who uses insulin from before hospitalization
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Shuhei Middle name Last name Nishina
Organization	Kansai Rosai Hospital
Division name	Department of Diabetes and Endocrinology
Zip code	650-8511
Address	3-1-69, Inabaso, Amagasaki-shi, Hyogo
TEL	06-6416-1221
Email	shuhee247@yahoo.co.jp

Public contact
Name of contact person	1st name Shuhei Middle name Last name Nishina
Organization	Kansai Rosai Hospital
Division name	Department of Diabetes and Endocrinology
Zip code	660-8511
Address	3-1-69, Inabaso, Amagasaki-shi, Hyogo
TEL	06-6416-1221
Homepage URL
Email	shuhee247@yahoo.co.jp

Sponsor
Institute	Department of Diabetes and Endocrinology, Kansai Rosai Hospital
Institute
Department

Funding Source
Organization	Kansai Rosai Hospital
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	Kansai Rosai Hospital
Address	3-1-69, Inabaso, Amagasaki-shi, Hyogo
Tel	06-6416-1221
Email	postmaster@kansaih.johas.go.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	関西労災病院(兵庫県）

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 04 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	34
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	Completed
Date of protocol fixation	2018 Year 08 Month 31 Day
Date of IRB	2018 Year 10 Month 01 Day
Anticipated trial start date	2018 Year 09 Month 03 Day
Last follow-up date	2019 Year 05 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	2019 Year 02 Month 03 Day
Last modified on	2019 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038738