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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029550
Receipt No. 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 2019/04/16

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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
Email 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
Email okaji@nms.ac.jp

Sponsor
Institute Division of Endocrinology, Department of Medicine, Nippon Medical School Chiba-Hokusoh Hospital
Institute
Department

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
Email 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
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
2019 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033762

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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