UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028634 |
|---|---|
| Receipt number | R000032772 |
| Scientific Title | Multicenter trial of effects for glucometabolism, platelet activation marker and inflammatory marker by single or combinathin therapy with tofogliflozin and anagliptin in type 2 diabetic patients |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2024/08/15 10:21:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multicenter trial of effects for glucometabolism, platelet activation marker and inflammatory marker by single or combinathin therapy with tofogliflozin and anagliptin in type 2 diabetic patients
Acronym
Kansai - Collaborative Anti-atherothrombotic Medicine study group
Scientific Title
Multicenter trial of effects for glucometabolism, platelet activation marker and inflammatory marker by single or combinathin therapy with tofogliflozin and anagliptin in type 2 diabetic patients
Scientific Title:Acronym
Kansai - Collaborative Anti-atherothrombotic Medicine study group
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
pass
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of HbA1c during 24 weeks from baseline
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
tofogliflozin
Interventions/Control_2
anagliptin
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
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. under treatment by dialy DPP-4 blocker
2. 7.5% < HbA1c < 9.0%
3. BMI > 18.0 kg/m2
4. 20 years < age < 95 years
5. written informed concent
Key exclusion criteria
1. type 1 diabetes or secondary diabetes
2. contraindication for medicine
3. allergy
4. eGFR < 30mL/min/1.73m2
5. AST or ALT > 120IU/L
6. history of appoplexy
7. pregnancy or lactationperiod
8. urinary infection, social disease
9. malignancy
10. inappropriate patients
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shosaku Nomura |
Organization
Kansai Medical University
Division name
First Department of Internal Medicine
Zip code
Address
2-5-1, Shin-machi, Hirakata, Osaka 573-1010 Japan
TEL
0728042754
nomurash@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shosaku Nomura |
Organization
Kansai Medical University
Division name
First Department of Internal Medicine
Zip code
Address
2-5-1, Shin-machi, Hirakata, Osaka 573-1010 Japan
TEL
0728042754
Homepage URL
nomurash@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
pass
Organization
Division
Category of Funding Organization
Profit organization
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
| 2017 | Year | 09 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 10 | Day |
Last modified on
| 2024 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032772
