UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035758 |
|---|---|
| Receipt number | R000038738 |
| Scientific Title | 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 | 2019/07/09 15:50:01 |
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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
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
shuhee247@yahoo.co.jp
Sponsor or person
Institute
Department of Diabetes and Endocrinology, Kansai Rosai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038738
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
