UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035431 |
|---|---|
| Receipt number | R000040364 |
| Scientific Title | insulin injection new entry (IINE) trial |
| Date of disclosure of the study information | 2019/01/04 |
| Last modified on | 2019/01/03 18:03:15 |
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Basic information
Public title
insulin injection new entry (IINE) trial
Acronym
IINE trial
Scientific Title
insulin injection new entry (IINE) trial
Scientific Title:Acronym
IINE trial
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 the efficacy and safety of once-daily insulin degludec/insulin aspart (IDegAsp) or once-daily second-generation basal insulin analogs in Japanese adults with type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
percent change in HbA1c
Key secondary outcomes
daily insulin requirement
hypoglycemic episodes
body mass index
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
once-daily insulin degludec/insulin aspart (IDegAsp)
Interventions/Control_2
once-daily second-generation basal insulin analogs
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
Japanese insulin-naive adults with type 2 diabetes, aged more than 20 years with HbA1c more than 7% and a body mass index of less than 35 kg/m2.
Key exclusion criteria
Subjects with type 1 diabetes, secondary diabetes, severe renal disease, severe hepatic disease.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiya Shimoda |
Organization
Prefectural University of Kumamoto
Division name
Faculty of Environmental and Symbiotic Sciences
Zip code
Address
3-1-100 Tsukide Higashi-ku, Kumamoto, Kumamoto 862-8502, Japan
TEL
+81-96-321-6691
sshimoda@pu-kumamoto.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiya Shimoda |
Organization
Prefectural University of Kumamoto
Division name
Faculty of Environmental and Symbiotic Sciences
Zip code
Address
3-1-100 Tsukide Higashi-ku, Kumamoto, Kumamoto 862-8502, Japan
TEL
+81-96-321-6691
Homepage URL
sshimoda@pu-kumamoto.ac.jp
Sponsor or person
Institute
Prefectural University of Kumamoto
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 01 | 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
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
| 2017 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 03 | Day |
Last modified on
| 2019 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040364
