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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025199
Receipt No. R000028989
Scientific Title The efficacy of insulin degludec/insulin aspart switching from insulin glargine or degludec about glycemic metabolism in type 2 diabetes patients
Date of disclosure of the study information 2016/12/09
Last modified on 2019/04/09

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Basic information
Public title The efficacy of insulin degludec/insulin aspart switching from insulin glargine or degludec about glycemic metabolism in type 2 diabetes patients
Acronym The efficacy of insulin degludec/insulin aspart switching from existing long acting insulin in type 2 diabetes patients
Scientific Title The efficacy of insulin degludec/insulin aspart switching from insulin glargine or degludec about glycemic metabolism in type 2 diabetes patients
Scientific Title:Acronym The efficacy of insulin degludec/insulin aspart switching from existing long acting insulin in type 2 diabetes patients
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess postprandial blood glucose, HbA1c and incidence rate of hypoglycemia by insulin degludec/insulin aspart compared with insulin degludec or insulin glargine
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Difference between pre-prandial blood glucose level and postprandial blood glucose level in main meal measured by SMBG at 12 weeks after intervention.
Key secondary outcomes 1) Glucose variability measured by SMBG
2) Blood and urine test (including HbA1c)
3) Body weight
4) Incidence rate of hypoglycemia
5) Dose of insulin and other antidiabetic agent

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 YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Keeping insulin degludec or insulin glargine
Interventions/Control_2 Switching from insulin degludec or insulin glargine to insulin degludec/insulin aspart
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients who were 20-year-old to 80-year-old at the time of obtaining informed consent
2) Patients whose HbA1c level is more than 6.0% and less than 9.0% at the time of obtaining informed consent
3) Patients who were taking insulin degludec or insulin glargine once daily more than three months and measuring their blood glucose by SMBG
4) Patients who are able to understand the study and willing to provide written informed consent
Key exclusion criteria 1) Patients with hypersensitivity to insulin degludec/ insulin aspart
2) Patients with severe or unstable retinopathy
3) Patients with severe liver or kidney dysfunction
4) Patients with pregnancy
5) Patients with severe diabetic ketosis, diabetic coma
6) Patients who are obviously bad adherence of diet.
7) Patients who needs intensive insulin therapy due to whose insulin depletion
8) Patients who are deemed to be unsuitable by the investigator
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Hideaki
Middle name
Last name Miyoshi
Organization Hokkaido University
Division name Division of Diabetes and Obesity, Faculty of Medicine and Graduate School of Medicine
Zip code 060-8638
Address n15, w7, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-8192
Email hmiyoshi@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Kyu Yong
Middle name
Last name Cho
Organization Hokkaido University Hospital
Division name Department of Medicine 2/Clinical Research and Medical Innovation Center
Zip code 060-8648
Address n14, w5, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-7735
Homepage URL
Email kyuyong-cho@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Self founding
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 Hokkaido University Hospital Division of Clinical Research Administration
Address n14w5, kita-ku, Sapporo, Hokkaido, Japan
Tel 011-701-7636
Email crjimu@huhp.hokudai.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 北海道大学病院(北海道)、青木内科クリニック(北海道)、沖医院(北海道)、釧路赤十字病院(北海道)、栗原内科(北海道)、栗山赤十字病院(北海道)、苫小牧市立病院(北海道)、北海道せき損センター(北海道)、北海道中央労災病院(北海道)、萬田記念病院(北海道)

Other administrative information
Date of disclosure of the study information
2016 Year 12 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 60
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
2016 Year 11 Month 13 Day
Date of IRB
2016 Year 12 Month 12 Day
Anticipated trial start date
2016 Year 12 Month 19 Day
Last follow-up date
2018 Year 09 Month 30 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 12 Month 09 Day
Last modified on
2019 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028989

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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