UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy and the safety of the new long-acting insulin in patient with diabetes
Acronym	The efficacy and the safety of the new long-acting insulin in patient with diabetes
Scientific Title	The efficacy and the safety of the new long-acting insulin in patient with diabetes
Scientific Title:Acronym	The efficacy and the safety of the new long-acting insulin in patient with diabetes
Region	Japan

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

Objectives
Narrative objectives1	To compare an new long-acting insulin with existing diabetes therapeutic drug for efficacy and safety in diabetes
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in HbA1c, the body weight, the custom-built diabetes treatment satisfaction questionnaire result and adverse events including hypoglycemia at 24weeks later from an examination start
Key secondary outcomes	From an examination start, it is the following items 24 weeks later -Achievement rate of HbA1c<7.0% and<8.0% -Change in fasting blood glucose -Glycemic variability by SMBG -Change in insulin dose(daily basal insulin doses, daily total insulin doses)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	concentrated preparation of insulin glargine The dosing period is from start of examination to implementation of the questionnaire 3~6 months after.We set the dose to the target of less than HbA1c7%.The patients take blood test and examination every 1~2 months.
Interventions/Control_2	insulin degludec including the premixed insulin preparations The dosing period is from start of examination to implementation of the questionnaire 3~6 months after.We set the dose to the target of less than HbA1c7%.The patients take blood test and examination every 1~2 months.
Interventions/Control_3	Continuing with the treatment so far The dosing period is from start of examination to implementation of the questionnaire 3~6 months after.We set the dose to the target of less than HbA1c7%.The patients take blood test and examination every 1~2 months.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients whose HbA1c are more than 8.0% or who are already using insulin
Key exclusion criteria	Contraindicated patient in the attached document of the insulin preparations Contraindicated patient in the attached document of diabetes drugs Hypoglycemic risk Serious heart trouble Severe hepatic dysfunction Severe renal dysfunction Internal secretion disease Needs the steroid dosage Patients judged by the investigator to be ineligible for some other reason
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Koichiro Yasuda
Organization	Osaka Saiseikai Noe Hospital
Division name	Department of Diabetes and Endocrinology
Zip code
Address	1-3-25, Furuichi, Jyoto-ku, Osaka-shi, Osaka, 536-0001, Japan
TEL	06-6932-0401
Email	kyasuda@noe.saiseikai.or.jp

Public contact
Name of contact person	1st name Middle name Last name Mitsuru Ota
Organization	Osaka Saiseikai Noe Hospital
Division name	Department of Diabetes and Endocrinology
Zip code
Address	1-3-25, Furuichi, Jyoto-ku, Osaka-shi, Osaka, 536-0001, Japan
TEL	06-6932-0401
Homepage URL
Email	mitsuru.ota@noe.saiseikai.or.jp

Sponsor
Institute	Osaka Saiseikai Noe Hospital
Institute
Department

Funding Source
Organization	Osaka Saiseikai Noe Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization
Address
Tel
Email

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	大阪府済生会野江病院(大阪府)/Osaka Saiseikai Noe Hospital (Osaka)

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 11 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	2016 Year 01 Month 11 Day
Date of IRB	2016 Year 01 Month 11 Day
Anticipated trial start date	2016 Year 01 Month 11 Day
Last follow-up date	2018 Year 01 Month 11 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 01 Month 11 Day
Last modified on	2019 Year 07 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023691