UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025771 |
|---|---|
| Receipt number | R000029107 |
| Scientific Title | Effects of Long-term Dapagliflozin Treatment on Hemorheology, Leukocyte Activation and Oxidative Stress |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2021/01/26 14:22:55 |
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Basic information
Public title
Effects of Long-term Dapagliflozin Treatment on Hemorheology, Leukocyte Activation and Oxidative Stress
Acronym
Effects of Long-term Dapagliflozin Treatment on Hemorheology, Leukocyte Activation and Oxidative Stress
Scientific Title
Effects of Long-term Dapagliflozin Treatment on Hemorheology, Leukocyte Activation and Oxidative Stress
Scientific Title:Acronym
Effects of Long-term Dapagliflozin Treatment on Hemorheology, Leukocyte Activation and Oxidative Stress
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the hypothesis that 16 weeks of treatment with dapagliflozin is, despite mildly elevated haematocrit, noninferior in terms of hemorheology to the non-dapagliflozin treatment group (conventional treatment group), and to furthermore study the effect on leukocyte activation and oxidative stress.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Whole blood transit time (0.1 mL) and the difference from baseline at 16 weeks after enrollment, as assessed using the microchannel array flow analyzer (MC-FAN) equipped with BK 7-7-7D chip
Key secondary outcomes
Blood samples at 8 and 16 weeks after enrollment (whole blood transit time (0.1 mL) and difference from baseline as determined using the MC-FAN with DKAMCM1-60-7-4.5D, leukocyte activation (adhesive leukocyte count as determined using the MC-FAN with DKAMCM1-60-7-4.5D , difference between whole blood transit time in heparin (5% vol) blood samples and whole blood transit time in EDTA-2Na + heparin blood samples as determined using the DKAMCM1-60-7-4.5D), CBC, lipid system, hsCRP, serum creatinine, hydroperoxide levels as serum levels of reactive oxygen metabolite (d-ROM) and antioxidant potencial as determined by BAP test using F.R.E.E. carpe diem (Diacron srl, Grosseto, Italy) and urine samples (albuminuria assay); whole blood transit time (0.1 mL) and difference from baseline as determined using the MC-FAN 7-7-7D chip at 8 weeks after enrollment; and percentage in which whole blood transit time (0.1 mL) did not increase =>6.0sec(15%), as determined using MC-FAN at 8 and 16 weeks after enrollment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dapagliflozin treatment group: Oral dapagliflozin 5 mg/day in combination with standard therapy (the dapagliflozin dose can be increased to 10 mg in subjects with inadequate response to 5 mg)
Interventions/Control_2
Non-dapagliflozin treatment group: Optimal diabetes treatment other than an SGLT2 inhibitor in combination with standard therapy
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(a) 20 to 75 years of age at informed consent
(b) Type 2 diabetes mellitus patient, with HbA1c>7.0%
(c) Diabetic nephropathy stage <=3
(d) Patients visiting the hospital on an outpatient basis for diabetic therapy, who provide written informed consent
Key exclusion criteria
(a) Patients with type 1 diabetes mellitus
(b) Patients with a medical history of hypersensitivity to any of the ingredients of dapagliflozin
(c) Patients with severe ketosis or diabetic coma or pre-coma
(d) Patients who have severe infection, are pre- or postoperative, or have sustained serious trauma
(e) Patients with severe impaired liver function
(f) Patients who are susceptible to dehydration
(g) Patients with urinary tract infection or genital infection
(h) Patients with a history of cerebrovascular disease within the last 3 months
(i) Women who are pregnant or breastfeeding or who may be pregnant
(j) Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 mL
(k) Patients on warfarin or a novel oral anticoagulant (NOAC) (dabigatran, rivaroxaban, edoxaban, or apixaban)
(l) Current smokers
(m) Patients otherwise deemed to be unsuitable for the clinical study by investigators
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Yasu |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Deparment of Cardiovascular Medicine and Nephrology
Zip code
321-2593
Address
632 Takatoku, Nikko City, Tochigi
TEL
0288-76-1515
tyasu@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Niijima |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Clinical Study Support Center
Zip code
321-2593
Address
632 Takatoku, Nikko City, Tochigi
TEL
0288-76-1515
Homepage URL
aniijima@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Nikko Medical Center
Department of Clinical Study Support Center
Institute
Department
Personal name
Funding Source
Organization
ONO Pharmaceutical CO.,LTD.
AstraZeneca K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Cardiovascular Medicine,Nephrology and Neurology,University of the Ryukyus.
Yokokawa Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo Medical University Nikko Medical Center IRB
Address
632 Takatoku, Nikko City, Tochigi
Tel
0288-76-1515
rinshokenkyu@dokkyomed.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
獨協医科大学日光医療センター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | 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
90
Results
Hepatocrit was increased by about 2% after 16 weeks of dosage of depagliflosin in type 2 diabetes patients, but proved to be inferior in terms of blood fluidity compared to the conventional treatment group
Results date posted
| 2019 | Year | 07 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The subject of the relevant clinical research
Type 2 diabetes mellitus patient,with HbA1c>7.0% Diabetic nephropathy stage<=3 Age 20 to 75 at the time of consent acquisition
Comparison group
Assigned to Dapagliflozin administration group and non-administration group
Dapagliflozin treatment is a combination treatment of Dapagliflozin 5mg / day orally with basic treatment (can be increased to 10mg for cases with insufficient effect)
Non-administration group is treated with basic treatment combined with appropriate diabetes treatment other than SGLT2 inhibitor
Participant flow
2017/4/26 First person consent acquisition / examination start
2017/3/31 Number of consent holders: 43 Number of consent withdrawals: 1
2018/11/28 90th (final) consent obtained
2019/3/20 End of observation Consent withdrawal number of people 5 Discontinuance number of people 4
Adverse events
Disease reports 1 case Other adverse events 9
Outcome measures
Hepatocrit was increased by about 2% after 16 weeks of dosage of depagliflosin in type 2 diabetes patients, but proved to be inferior in terms of blood fluidity compared to the conventional treatment group
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 20 | Day |
Last modified on
| 2021 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029107
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/07/26 | ★★【D-PATH】臨床研究実施計画書Ver1.5（琉大提出用）最終版.docx |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
