UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025122 |
|---|---|
| Receipt number | R000028871 |
| Scientific Title | An open-label randomized controlled trial on the efficacy of switching from insulin glargine U100 to insulin glargine U300 or insulin degludec in type2 diabetes mellitus |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2021/07/08 16:27:01 |
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Basic information
Public title
An open-label randomized controlled trial on the efficacy of switching from insulin glargine U100 to insulin glargine U300 or insulin degludec in type2 diabetes mellitus
Acronym
An open-label randomized controlled trial on the efficacy of switching from insulin glargine U100 to insulin glargine U300 or insulin degludec in type2 diabetes mellitus
Scientific Title
An open-label randomized controlled trial on the efficacy of switching from insulin glargine U100 to insulin glargine U300 or insulin degludec in type2 diabetes mellitus
Scientific Title:Acronym
An open-label randomized controlled trial on the efficacy of switching from insulin glargine U100 to insulin glargine U300 or insulin degludec in type2 diabetes mellitus
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of insulin glargine U300 and insulin degludec in type 2 diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Level of glycohemoglobin (HbA1c) at six months after switching basal insulin
Key secondary outcomes
Fasting blood glucose, body weight, frequency and severity of hypoglycemia, circadian variation in blood glucose (M Value), dosage of insulin, results of the questionnaire about quality of life (QOL) and device convenience
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Insulin glargine U300 will be administered daily for six months. Glargine U300 will be started at the same dose as glargine U100 administered before switching. The dosage of glargine U300 will be adjusted according to the levels of fasting blood glucose self-measured by patients.
Interventions/Control_2
Insulin degludec will be administered daily for six months. Glargine U300 will be started at the same dose as glargine U100 administered before switching. The dosage of degludec will be adjusted according to the levels of fasting blood glucose self-measured by patients.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients with type 2 diabetes who is administered insulin glargine U100 for over three months
Key exclusion criteria
Patients whose medications for diabetes (kinds or dosages of insulin, GLP-1 agonists or oral hypoglycemic agents) have been changed in last two months
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Suzuki, Rie Jo |
Organization
Kanagawa-ken Keiyu-kai Keiyu hospital
Division name
Department of internal medicine
Zip code
Address
3-7-3, Minatomirai, Nishi-ku, Yokohama, Kanagawa, Japan. 220-8521(Zip code)
TEL
045-221-8181
r.oga925@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rie Jo |
Organization
Kanagawa-ken Keiyu-kai Keiyu hospital
Division name
Department of internal medicine
Zip code
Address
3-7-3, Minatomirai, Nishi-ku, Yokohama, Kanagawa, Japan. 220-8521(Zip code)
TEL
045-221-8181
Homepage URL
r.oga925@nifty.com
Sponsor or person
Institute
Kanagawa-ken Keiyu-kai Keiyu hospital
Institute
Department
Personal name
Funding Source
Organization
Kanagawa-ken Keiyu-kai Keiyu hospital
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
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
一般財団法人神奈川県警友会 けいゆう病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 02 | Day |
Last modified on
| 2021 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028871
