UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024122 |
|---|---|
| Receipt number | 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 14:11:41 |
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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
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
takucchi@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027775
