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 |
Effects of Long-term Dapagliflozin Treatment on Hemorheology, Leukocyte Activation and Oxidative Stress
Effects of Long-term Dapagliflozin Treatment on Hemorheology, Leukocyte Activation and Oxidative Stress
Effects of Long-term Dapagliflozin Treatment on Hemorheology, Leukocyte Activation and Oxidative Stress
Effects of Long-term Dapagliflozin Treatment on Hemorheology, Leukocyte Activation and Oxidative Stress
Japan |
Type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
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.
Pharmacodynamics
Confirmatory
Pragmatic
Not applicable
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
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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
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)
Non-dapagliflozin treatment group: Optimal diabetes treatment other than an SGLT2 inhibitor in combination with standard therapy
20 | years-old | <= |
75 | years-old | >= |
Male and Female
(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
(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
90
1st name | Takanori |
Middle name | |
Last name | Yasu |
Dokkyo Medical University Nikko Medical Center
Deparment of Cardiovascular Medicine and Nephrology
321-2593
632 Takatoku, Nikko City, Tochigi
0288-76-1515
tyasu@dokkyomed.ac.jp
1st name | Akiko |
Middle name | |
Last name | Niijima |
Dokkyo Medical University Nikko Medical Center
Clinical Study Support Center
321-2593
632 Takatoku, Nikko City, Tochigi
0288-76-1515
aniijima@dokkyomed.ac.jp
Dokkyo Medical University Nikko Medical Center
Department of Clinical Study Support Center
ONO Pharmaceutical CO.,LTD.
AstraZeneca K.K.
Profit organization
Japan
Department of Cardiovascular Medicine,Nephrology and Neurology,University of the Ryukyus.
Yokokawa Clinic
Dokkyo Medical University Nikko Medical Center IRB
632 Takatoku, Nikko City, Tochigi
0288-76-1515
rinshokenkyu@dokkyomed.ac.jp
NO
獨協医科大学日光医療センター
2017 | Year | 02 | Month | 01 | Day |
Unpublished
90
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
2019 | Year | 07 | Month | 24 | Day |
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
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
Disease reports 1 case Other adverse events 9
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
No longer recruiting
2017 | Year | 01 | Month | 19 | Day |
2016 | Year | 11 | Month | 26 | Day |
2017 | Year | 02 | Month | 20 | Day |
2019 | Year | 03 | Month | 20 | Day |
2017 | Year | 01 | Month | 20 | Day |
2021 | Year | 01 | Month | 26 | Day |
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 | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |