UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025771
Receipt No. 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 2019/07/24

* 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 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
Email 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
Email rinshokenkyu@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University Nikko Medical Center
Department of Clinical Study Support Center
Institute
Department

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
Email 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
2019 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029107

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.