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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035758
Receipt No. R000038738
Official scientific title of the study A clinical trial of introduction and adjustment of insulin Degludec in hospitalized patients with type 2 diabetes
Date of disclosure of the study information 2019/02/04
Last modified on 2019/02/13

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Basic information
Official scientific title of the study A clinical trial of introduction and adjustment of insulin Degludec in hospitalized patients with type 2 diabetes
Title of the study (Brief title) 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 Nishina Shuhei
Organization Kansai Rosai Hospital
Division name Department of Diabetes and Endocrinology
Address 3-1-69, Inabaso, Amagasaki-shi, Hyogo
TEL 06-6416-1221
Email shuhee247@yahoo.co.jp

Public contact
Name of contact person Nishina Shuhei
Organization Kansai Rosai Hospital
Division name Department of Diabetes and Endocrinology
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 08 Month 31 Day
Anticipated trial start date
2018 Year 09 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2019 Year 02 Month 03 Day
Last modified on
2019 Year 02 Month 13 Day


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

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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