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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Type 1 diabetes mellitus and type 2 diabetes mellitus | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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IRB Contact (For public release) | |
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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 |
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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 | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |