UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037642 |
|---|---|
| Receipt number | R000042920 |
| Scientific Title | A pilot clinical trial of introduction and adjustment algorithm of insulin degludec in hospitalized patients with type 2 diabetes. |
| Date of disclosure of the study information | 2019/08/09 |
| Last modified on | 2019/08/09 00:12:29 |
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Basic information
Public title
A pilot clinical trial of introduction and adjustment algorithm of insulin degludec in hospitalized patients with type 2 diabetes.
Acronym
I-deg trial
Scientific Title
A pilot clinical trial of introduction and adjustment algorithm of insulin degludec in hospitalized patients with type 2 diabetes.
Scientific Title:Acronym
I-deg trial
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In hospitalized patients with poor glycemic control, treatment is generally initiated with insulin to reverse glucose toxicity, but there is no established method for dose adjustment. We examined the efficacy and safety of an adjustment method of insulin degludec in hospitalized patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of days required to achieve a fasting blood glucose level of 130 mg/dl or less, hospitalization, hypoglycemia
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
hospitalized type2 diabetes patients at 2017/9-2018/3
Key exclusion criteria
a) The patient who became the hospitalization for an unexpected reason except the insulin adjustment.
The patient who other diseases including the b) malignant tumor were found out, and came to cannot but extend length of stay
c) Type I diabetes mellitus patient
d) The patient whom a factor to affect the blood sugar level including the steroid medicine clearly produced
e) The patient who does not adjust it using algorithm
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
650-8511
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 09 | 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
31
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
| 2019 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 19 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 30 | Day |
Other
Other related information
Retrospective cohort study
Management information
Registered date
| 2019 | Year | 08 | Month | 09 | Day |
Last modified on
| 2019 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042920
