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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024122
Receipt No. R000027775
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
Date of disclosure of the study information 2016/10/01
Last modified on 2017/09/22

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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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