UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021516 |
|---|---|
| Receipt number | R000023879 |
| Scientific Title | Effect of saxagliptin on endothelial function in patients with type 2 diabetes; Multi-center clinical trial |
| Date of disclosure of the study information | 2016/03/18 |
| Last modified on | 2018/06/12 15:29:17 |
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Basic information
Public title
Effect of saxagliptin on endothelial function in patients with type 2 diabetes; Multi-center clinical trial
Acronym
Effect of saxagliptin on endothelial function in patients with type 2 diabetes; Multi-center clinical trial
Scientific Title
Effect of saxagliptin on endothelial function in patients with type 2 diabetes; Multi-center clinical trial
Scientific Title:Acronym
Effect of saxagliptin on endothelial function in patients with type 2 diabetes; Multi-center clinical trial
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of saxagliptin on endothelial function in patients with type 2 diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in FMD from baseline to week 12
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of saxagliptin 5 mg once a day post breakfast.
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
1. Type 2 diabetes
2. >=20 of age at the time of informed consent acquisition
3. Type 2 diabetes with HbA1c (NGSP) >=7.0% and <9.0%
4.The patient provided written informed consent to participate in the study
Key exclusion criteria
1. Has history of hypersensitivity to ipragliflozin or any other excipient of saxagliptin
2. Has history of administration of DPP-4 inhibitor within 4 weeks before initiation of the study
3.patient with insulin dependent diabetes mellitus
4. Has history of myocardial infarction, angina, cerebral infarction, intracranial hemorrhage, subarachnoid hemorrhage, transient ischemic attacks within 3 months before initiation of the study
5. patient with ASO
6. With severe renal dysfunction (eGRF <50 mL/min or patient undergoing artificial dialysis)
7. Has history of severe ketosis, diabetic coma, or precoma within 6 months
8. Has history of cancer, severe infection
9. Pregnant, possibly pregnant, planned to become pregnant or nursing women
10. Are considered not eligible for the study by the attending doctor due to other reasons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihito Higashi |
Organization
Hiroshima University Hospital
Division name
Medical Center for Translational and Clinical Research
Zip code
Address
1-2-3 Kasumi, Minamiku, Hiroshima
TEL
082-257-5831
yhigashi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihito Higashi |
Organization
Hiroshima University Hospital
Division name
Medical Center for Translational and Clinical Research
Zip code
Address
1-2-3 Kasumi, Minamiku, Hiroshima
TEL
082-257-5831
Homepage URL
yhigashi@hiroshima-u.ac.jp
Sponsor or person
Institute
Medical Center for Translational and Clinical Research, Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
KYOWA KIRIN.
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
東京医科大学（東京都）、日本大学（東京都）、徳島大学（徳島）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 18 | 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
| 2016 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 02 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 09 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 12 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 17 | Day |
Last modified on
| 2018 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023879
