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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035431
Receipt No. R000040364
Official scientific title of the study insulin injection new entry (IINE) trial
Date of disclosure of the study information 2019/01/04
Last modified on 2019/01/03

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Basic information
Official scientific title of the study insulin injection new entry (IINE) trial
Title of the study (Brief title) 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 Seiya Shimoda
Organization Prefectural University of Kumamoto
Division name Faculty of Environmental and Symbiotic Sciences
Address 3-1-100 Tsukide Higashi-ku, Kumamoto, Kumamoto 862-8502, Japan
TEL +81-96-321-6691
Email sshimoda@pu-kumamoto.ac.jp

Public contact
Name of contact person Seiya Shimoda
Organization Prefectural University of Kumamoto
Division name Faculty of Environmental and Symbiotic Sciences
Address 3-1-100 Tsukide Higashi-ku, Kumamoto, Kumamoto 862-8502, Japan
TEL +81-96-321-6691
Homepage URL
Email sshimoda@pu-kumamoto.ac.jp

Sponsor
Institute Prefectural University of Kumamoto
Institute
Department

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 04 Month 27 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040364

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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