UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031947 |
|---|---|
| Receipt number | 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 | 2024/10/02 11:14:39 |
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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 and Medical Science
Zip code
770-8503
Address
3-18-15, Kuramoto-cho, Tokushima 770-8503, JAPAN
TEL
088-633-7120
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 and Medical Science
Zip code
770-8503
Address
3-18-15, Kuramoto-cho, Tokushima 770-8503, JAPAN
TEL
088-633-7120
Homepage URL
otoda.toshiki@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
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
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
123
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
under review
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
| 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
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 28 | Day |
Last modified on
| 2024 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036011
