UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027364 |
|---|---|
| Receipt number | R000031344 |
| Scientific Title | Investigation about insulin doses and blood glucose control in changes from insulin glargine U-100 to insulin glargine U-300 for patients with diabetes. |
| Date of disclosure of the study information | 2017/05/17 |
| Last modified on | 2020/11/27 15:15:20 |
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Basic information
Public title
Investigation about insulin doses and blood glucose control in changes from insulin glargine U-100 to insulin glargine U-300 for patients with diabetes.
Acronym
Investigation about insulin doses and blood glucose control in changes from insulin glargine U-100 to insulin glargine U-300 for patients with diabetes.
Scientific Title
Investigation about insulin doses and blood glucose control in changes from insulin glargine U-100 to insulin glargine U-300 for patients with diabetes.
Scientific Title:Acronym
Investigation about insulin doses and blood glucose control in changes from insulin glargine U-100 to insulin glargine U-300 for patients with diabetes.
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety between insulin glargine U-300 for diabetes patients receiving insulin glargine U-100, in addition to evaluate usability by using a questionnaire
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
satisfaction of the change to insulin glargine U-300 by using Questionnaire, insulin dose, bodyweight, BMI, glucose, a ratio of basal insulin (basal-bolou therapy), hypoglycemia (hypoglycemic symptom or glucose level at self monitering glucose)
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
To switch from insulin glargine U-100 to insulin glargin U-300.
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 gives a written informed.
2)The patient who is receiving treatment with insulin glargine u-100 by once or twice a day.
3)Male and Female,the age 20 years old or older.
Key exclusion criteria
1)The pregnant woman and/or a woman under breast-feeding.
2)The patient with intolerance of medical reasons by doctor.
3)The patients with hypersensitivity for insulin glargin U-300.
4)The patients with serious complications and considered inappropriate to participate in this study by the doctor in charge.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Toshie |
| Middle name | |
| Last name | Iijima |
Organization
Dokkyo Medical University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
321-0293
Address
880 kita-kobayashi, Mibu, Tochigi, 321-0293, Japan
TEL
0282-86-1111
toshie@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Toshie |
| Middle name | |
| Last name | Iijima |
Organization
Dokkyo Medical University Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
321-0293
Address
880 kita-kobayashi, Mibu, Tochigi, 321-0293, Japan
TEL
0282-86-1111
Homepage URL
toshie@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University
Address
880 kita-kobayashi, Mibu, Tochigi, 321-0293, Japan
Tel
0282-87-2275
r-kenkyu@dokkyomed.ac.jp
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
獨協医科大学病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 17 | 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 | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 16 | Day |
Last modified on
| 2020 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031344
