UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037963 |
|---|---|
| Receipt number | R000043273 |
| Scientific Title | The Kumamoto Insulin Degludec Observational (KIDUNA) Study |
| Date of disclosure of the study information | 2019/09/09 |
| Last modified on | 2019/09/08 15:58:01 |
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Basic information
Public title
The Kumamoto Insulin Degludec Observational (KIDUNA) Study
Acronym
KIDUNA Study
Scientific Title
The Kumamoto Insulin Degludec Observational (KIDUNA) Study
Scientific Title:Acronym
KIDUNA Study
Region
| Japan |
Condition
Condition
type 1 and type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present prospective observational study is to assess long-term efficacy and safety of insulin degludec (IDeg) as a part of a basal-bolus therapy for Japanese subjects with type 1 (T1D) or type 2 diabetes (T2D) in routine clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes in HbA1c from baseline at 3, 6 and 12 months
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult Japanese outpatients with T1D or T2D treated with the basal-bolus insulin therapy (BBT) using rapid-acting insulin analogue and long-acting insulin analogue
Key exclusion criteria
The exclusion criteria were pregnant or nursing women and subjects in whom the physician deemed IDeg treatment inappropriate.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Seiya |
| Middle name | |
| Last name | Shimoda |
Organization
Kumamoto university
Division name
Faculty of Life Sciences
Zip code
860-8556
Address
1-1-1 Honjo Chuo-Ku, Kumamoto 860-8556, Japan
TEL
096-373-5169
sshimoda@gpo.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Seiya |
| Middle name | |
| Last name | Shimoda |
Organization
Kumamoto university
Division name
Faculty of Life Sciences
Zip code
860-8556
Address
1-1-1 Honjo Chuo-Ku, Kumamoto 860-8556, Japan
TEL
096-373-5169
Homepage URL
sshimoda@gpo.kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto university
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Kumamoto university independent ethics committee
Address
1-1-1 Honjo Chuo-Ku, Kumamoto 860-8556, Japan
Tel
096-373-5657
iyg-igaku@jimu.kumamoto-u.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
| 2019 | Year | 09 | Month | 09 | Day |
Related information
URL releasing protocol
https://www.onlinelibrary.wiley.com/doi/full/10.1111/jdi.12496
Publication of results
Published
Result
URL related to results and publications
https://www.onlinelibrary.wiley.com/doi/full/10.1111/jdi.12496
Number of participants that the trial has enrolled
228
Results
The % changes in HbA1c of T1D and T2D subjects were -3.6% and -5.8%, respectively.
Results date posted
| 2019 | Year | 09 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
adult Japanese outpatients with T1D or T2D treated with the basal-bolus insulin therapy (BBT) using rapid-acting insulin analogue and long-acting insulin analogue
Participant flow
228 subjects completed the study
Adverse events
The percentage of subjects reporting AEs excluding hypoglycemia was 4.0% (n=9).
Acute bronchitis (0.9%, n=2), elevation of blood pressure (0.9%, n=2), infectious enteritis (0.4%, n=1), lumbago (0.4%, n=1), hyperkalemia (0.4%, n=1), reflux esophagitis (0.4%, n=1), symptoms of dumping syndrome (0.4%, n=1), first metatarsal bone fracture (0.4%, n=1) were reported.
Outcome measures
the changes in HbA1c from baseline at 3, 6 and 12 months
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2013 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2013 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
HbA1c, BMI, and insulin dose were recorded at the time of switching to IDeg, as well as at 1, 2, 3, 6, 9 and 12 months after switching.
Safety was assessed on the basis of hypoglycemic episodes and adverse events (AEs). The frequency of hypoglycemic episodes per month from 3 to 6 months, after stable glycemic control and stable insulin dose were achieved by active titration, after switching was compared with that for 1-month before switching
Management information
Registered date
| 2019 | Year | 09 | Month | 08 | Day |
Last modified on
| 2019 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043273
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| Registered date | File name |
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