UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029550 |
|---|---|
| Receipt number | R000033762 |
| Scientific Title | The mechanism of the preventive effect on nocturnal hypoglycemia by sodium glucose cotransporter 2 inhibitors |
| Date of disclosure of the study information | 2017/10/14 |
| Last modified on | 2021/04/17 12:25:10 |
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Basic information
Public title
The mechanism of the preventive effect on nocturnal hypoglycemia by sodium glucose cotransporter 2 inhibitors
Acronym
The mechanism of the preventive effect on nocturnal hypoglycemia by SGLT 2 inhibitors
Scientific Title
The mechanism of the preventive effect on nocturnal hypoglycemia by sodium glucose cotransporter 2 inhibitors
Scientific Title:Acronym
The mechanism of the preventive effect on nocturnal hypoglycemia by SGLT 2 inhibitors
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare the preventive effects on nocturnal hypoglycemia with several SGLT2 inhibitors and clarify the mechanism of these effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency of the nocturnal hypoglycemia estimated by continuous glucose monitoring system.
The levels of the gluconeogenesis inducible factors at 2 am.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Basal-bolus insulin therapy
Interventions/Control_2
Basal-bolus insulin therapy + canagliflozin
Interventions/Control_3
Basal-bolus insulin therapy + dapagliflozin
Interventions/Control_4
Basal-bolus insulin therapy + empagliflozin
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The type 2 diabetes patients who had consented for hospitalization for diabetic control and education of diabetes.
Key exclusion criteria
Subjects were excluded if they had been previously treated with insulin; were positive for anti-glutamic acid decarboxylase antibody; or had history or evidence of any carcinoma, endocrine disease, recent myocardial infarction, heart failure, or cerebrovascular disease.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Fumitaka |
| Middle name | |
| Last name | Okajima |
Organization
Nippon Medical School Chiba-Hokusoh Hospital
Division name
Division of Endocrinology, Department of Medicine
Zip code
270-1694
Address
1715 Kamagari, Inzai, Chiba, Japan
TEL
0476-99-1111
okaji@nms.ac.jp
Public contact
Name of contact person
| 1st name | Fumitaka |
| Middle name | |
| Last name | Okajima |
Organization
Nippon Medical School Chiba-Hokusoh Hospital
Division name
Division of Endocrinology, Department of Medicine
Zip code
270-1694
Address
1715 Kamagari, Inzai, Chiba, Japan
TEL
0476-99-1111
Homepage URL
okaji@nms.ac.jp
Sponsor or person
Institute
Division of Endocrinology, Department of Medicine, Nippon Medical School Chiba-Hokusoh Hospital
Institute
Department
Personal name
Funding Source
Organization
Division of Endocrinology, Department of Medicine, Nippon Medical School Chiba-Hokusoh 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
IRB in Nippon Medical School Chiba-Hokusoh Hospital
Address
1715 Kamagari, Inzai, Chiba, Japan
Tel
0476-99-1111
meiko-hirota@nms.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 14 | Day |
Last modified on
| 2021 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033762
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
