UMIN-CTR Clinical Trial

Basic information
Public title	Investigation about the diabetes treatment satisfaction and the usability of insulin injector by the change to insulin glargine U-300 in type 1 and type2 diabetes patients under treatment with sustained-release dissolution insulin
Acronym	Investigation about the diabetes treatment satisfaction and the usability of insulin injector by the change to insulin glargine U-300.
Scientific Title	Investigation about the diabetes treatment satisfaction and the usability of insulin injector by the change to insulin glargine U-300 in type 1 and type2 diabetes patients under treatment with sustained-release dissolution insulin
Scientific Title:Acronym	Investigation about the diabetes treatment satisfaction and the usability of insulin injector by the change to insulin glargine U-300.
Region	Japan

Condition
Condition	Type 1 diabetes mellitus and type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is aimed to investigate the diabetes treatment satisfaction and the usability of insulin injector by the change to insulin glargine U-300 in type 1 and type2 diabetes patients under treatment with sustained-release dissolution insulin.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	usability and satisfaction of the change to insulin glargine U-300 by using Questionnaire
Key secondary outcomes	Change in bodyweight,insulin dose,glucose (fasting),HbA1c,GA,CPR,TG,TC,LDL-C,HDL-C,ALT(GPT),AST(GOT),GTP,Uric acid,Creatinine,Urine microalbumin,blood pressure,adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients who use sustained release dissolution insulin will be switched to Insulin glargine U300 at same dosage,except for in case there is necessity to change insulin dosage for clinical reason such as hypoglycemia prevention.In such cases,attending physicians judge the insulin dosage.
Interventions/Control_2
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	1) The patient who had a diagnosis of type 1 and 2 diabetes. 2) The patient who is more than HbA1C 7 % and receiving treatment with sustained-release dissolution insulin by once a day more than three months. 3) Male and Female,the age 20 years old or older.
Key exclusion criteria	1) The patients are pregnant or have possibility of pregnancy. 2) The patients with hypersensitivity for Insulin Glargin U-300. 3) The patients with serious complications and considered inappropriate to participate in this study by the doctor in charge. 4) The patients whose HbA1c fluctuated more than 1.0% within the past three months.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takujiro Iuchi
Organization	Saitama Medical University Hospital
Division name	Department Endocrinology and Diabetes
Zip code
Address	350-0495 morohongo38,Moroyama-cho,Iruma-gun,Saitama-ken,Japan
TEL	049-276-1280
Email	takucchi@saitama-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takujiro Iuchi
Organization	Saitama Medical University Hospital
Division name	Department Endocrinology and Diabetes
Zip code
Address	350-0495 morohongo38,Moroyama-cho,Iruma-gun,Saitama-ken,Japan
TEL	049-276-1280
Homepage URL
Email	takucchi@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University Hospital
Institute
Department

Funding Source
Organization	Saitama Medical University Hospital
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
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

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

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 09 Month 15 Day
Date of IRB
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 09 Month 22 Day

Other
Other related information

Management information
Registered date	2016 Year 09 Month 21 Day
Last modified on	2017 Year 09 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027775

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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