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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031947
Receipt No. R000036011
Scientific Title A study on multifaceted clinical effects of SGLT2 inhibitors
Date of disclosure of the study information 2018/05/01
Last modified on 2021/04/24

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Basic information
Public title A study on multifaceted clinical effects of SGLT2 inhibitors
Acronym Multifaceted clinical effects of SGLT2 inhibitors
Scientific Title A study on multifaceted clinical effects of SGLT2 inhibitors
Scientific Title:Acronym Multifaceted clinical effects of SGLT2 inhibitors
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Cardiology Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To determine the beneficial effects of SGLT2 inhibitors on multiple cardiovascular and renal risk parameters
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c levels, urinary albumin-to-creatinine ratio, and urinary L-FABP-to-creatinine ratio over 16 weeks
Key secondary outcomes

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 Patients receive SGLT2 inhibitors for 16 weeks.
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 Participants were eligible if they were at least 20 years old, had type 2 diabetes mellitus, poorly controlled diabetes (HbA1c levels >6.9% within 12 weeks before screening), and had been treated with diet therapy and/or a single OHA, such as sulfonylurea (SU), biguanide (BG), thiazolidinedione (TZD) or dipeptidyl peptidase-4 (DPP-4) inhibitor class drugs, for 12 weeks or longer.
Key exclusion criteria Exclusion criteria were: (1) hypersensitivity or a contraindication to sitagliptin or voglibose; (2) history of type 1 diabetes; (3) history of ketoacidosis; (4) having experienced symptoms of hypoglycemia; (5) treatment with sitagliptin or voglibose within 12 weeks before screening; (6) treatment with insulin within 12 weeks before screening; (7) concomitant corticosteroid therapy; (8) poorly controlled or unstable diabetes (the state with ketoacidosis or with an increase in HbA1c >3% in the 12 weeks before screening); (9) alanine aminotransferase and/or aspartate aminotransferase levels more than 2.5-fold the upper limit of normal; (10) poorly controlled hypertension or systolic blood pressure >160 mm/Hg or diastolic blood pressure >100 mm/Hg; (11) presence of a severe health problem not suitable for the study; (12) pregnancy or breastfeeding; or (13) inability to participate in the study due to psychiatric or psychosocial status as assessed by the investigators.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Toshiki
Middle name
Last name Otoda
Organization Tokushima University Graduate School of Biomedical Sciences
Division name Department of Community Medicine for Diabetes and Metabolic Disorders
Zip code 770-8503
Address 3-18-15, Kuramoto-cho, Tokushima 770-8503, JAPAN
TEL 088-633-7120
Email otoda.toshiki@tokushima-u.ac.jp

Public contact
Name of contact person
1st name Toshiki
Middle name
Last name Otoda
Organization Tokushima University Graduate School of Biomedical Sciences
Division name Department of Community Medicine for Diabetes and Metabolic Disorders
Zip code 770-8503
Address 3-18-15, Kuramoto-cho, Tokushima 770-8503, JAPAN
TEL 088-633-7120
Homepage URL
Email otoda.toshiki@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

Funding Source
Organization Tokushima University
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 Tokushima University
Address 2-50-1, Kuramoto-cho, Tokushima 770-8503, JAPAN
Tel 088-633-9294
Email first-ec@tokushima-u.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
2018 Year 05 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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 28 Day
Date of IRB
2018 Year 04 Month 23 Day
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
2021 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
2018 Year 03 Month 28 Day
Last modified on
2021 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036011

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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