UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021290 |
|---|---|
| Receipt number | R000019565 |
| Scientific Title | The difference between earlier and later insulin therapy in protective effect on beta-cell function |
| Date of disclosure of the study information | 2016/03/02 |
| Last modified on | 2023/08/21 10:39:59 |
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Basic information
Public title
The difference between earlier and later insulin therapy in protective effect on beta-cell function
Acronym
The difference between earlier and later insulin therapy in protective effect on beta-cell function
Scientific Title
The difference between earlier and later insulin therapy in protective effect on beta-cell function
Scientific Title:Acronym
The difference between earlier and later insulin therapy in protective effect on beta-cell function
Region
| Japan |
Condition
Condition
T2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We make it clear whether there is difference in protective effect of insulin therapy on beta-cell function between an early and late stage of diabetes. This study would lead to clarify the significance of insulin therapy at an early stage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Change of insulin secretory capacity
Key secondary outcomes
2. Correlation between change of insulin secretory capacity and clinical background
3. The items related to insulin therapy
2-1.The ratio of subjects leaving insulin therapy
2-2.Period until leaving insulin therapy
2-3.Insulin dose in subjects continuing insulin
2-4.Frequency of hypoglycemia and change of body weight in subjects with insulin
4. Examination item only for subjects leaving insulin therapy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
Start insulin therapy. Subjects that meet "the insulin treatment withdrawal criteria" during a follow-up period finish insulin and start DPP-4 inhibitor.
An intervention period is until it meets the omission standard after change to DPP-4 inhibitor or from an intervention start to 72 weeks.
Interventions/Control_2
Start insulin therapy. Subjects that do not meet "the insulin treatment withdrawal criteria" during a follow-up period continue insulin therapy.An intervention period is from start to 72 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes untreated in HbA1c 9.0% or more, HbA1c 8.0% or more despite in diabetes drug use, who needs insulin introduction. And, admitted to Devision of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School hospital. (Who have to do basal bolus therapy and self-monitoring of blood glucose.)
Key exclusion criteria
A)Under 20 years old
B)treatment insulin
C)Under insulin treatment within 12 months
D)Diabetic coma
E)Dysautonomia
F)Unconscious hypoglycemia
G)Advanced retinopathy (preproliferative diabetic retinopathy / preproliferative diabetic retinopathy)
H)Renal dysfunction (eGFR<30mL/min)
I)Infection
J)During treatment or treatment plan of malignant neoplasm
K)Autoimmune disease
L)Use of Steroid medicine and/or immunosuppressor
M)Active liver disease (ALT or AST >100IU/L or total bilirubin level >2.5 mg/dL)
N)Pregnant, possibility of pregnancy, nursing or hope to become pregnant during the study period
O)In addition, principal investigator or researcher deems inappropriate as a target
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Shimoda |
Organization
Kawasaki Medical SchoolKawasaki Medical School
Division name
Division of Diabetes, Endocrinology and Metabolism
Zip code
7010192
Address
577 Matushima, Kurashiki, Okayama
TEL
086-462-1111
masashi-s@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Shimoda |
Organization
Kawasaki Medical School
Division name
Division of Diabetes, Endocrinology and Metabolism
Zip code
7010192
Address
577 Matushima, Kurashiki, Okayama
TEL
086-462-1111
Homepage URL
masashi-s@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Division of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Division of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School
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
Kawasaki medical school and hospital ethics committee
Address
577 Matushima, Kurashiki, Okayama
Tel
086-464-1076
kmsrec@med.kawasaki-m.ac.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
| 2016 | Year | 03 | Month | 02 | 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
69
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
| 2015 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 17 | 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 | 03 | Month | 02 | Day |
Last modified on
| 2023 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019565
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
