UMIN-CTR Clinical Trial

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
Last 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
1st 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