UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020984 |
|---|---|
| Receipt number | R000024221 |
| Scientific Title | The clinical study to explore the effects of SGLT2-inhibitors or DPP-4 inhibitors in Japanese patients with type 2 diabetes. |
| Date of disclosure of the study information | 2016/02/28 |
| Last modified on | 2016/02/12 00:23:36 |
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Basic information
Public title
The clinical study to explore the effects of SGLT2-inhibitors or DPP-4 inhibitors in Japanese patients with type 2 diabetes.
Acronym
The clinical study to explore the effects of SGLT2-inhibitors or DPP-4 inhibitors.
Scientific Title
The clinical study to explore the effects of SGLT2-inhibitors or DPP-4 inhibitors in Japanese patients with type 2 diabetes.
Scientific Title:Acronym
The clinical study to explore the effects of SGLT2-inhibitors or DPP-4 inhibitors.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effects of SGLT2-i or DPP4-i on responses of HbA1c,lipid parameters,liver function,BW, BP, central BP parameters in Japanese patients with type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HbA1c
Key secondary outcomes
Small dense LDL-C, Large LDL-C
HDL2,3-C, RLP-C, liver function,
Fatty acid composition
Amino acid composition, BW,BP, Central BP parameters, ABPM
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dapagliflozin 5 mg once a day for 6months
Interventions/Control_2
Sitagliptin 50 mg once a day for 6months
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Outpatients with type 2 diabetes (HbA1c:6.5-9.4%) who were attended to Showa University Hospital (Tokyo, Japan)
2.Patients who are 20-65 years old
3.Patients who themselves can voluntarily provide consent to participate in this study
Key exclusion criteria
1.Patients who are acute disease
2.Patients who are past history of hypersensitivity to anagliptin
3.Pregnant or woman of child-bearing potential
4.Patients whose eGFR are within 60mL/min/1.73m2
5.Patients who are judged as inappropriate for inclusion by phsicians
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Hayashi |
Organization
Showa University School of Medicine
Division name
Division of Diabetes and Endocrinology, Department of Internal Medicine
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8000
t-hayashi@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Hayashi |
Organization
Showa University School of Medicine
Division name
Division of Diabetes and Endocrinology, Department of Internal Medicine
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8000
Homepage URL
t-hayashi@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University School of Medicine, Division of Diabetes and Endocrinology, Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Showa University School of Medicine, Division of Diabetes and Endocrinology, Department of Internal Medicine
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 28 | 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
| 2013 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 12 | Day |
Last modified on
| 2016 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024221
| 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 |
