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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020427
Receipt No. R000023590
Scientific Title Study of Luseogliflozin against hypertension merger diabetes patients
Date of disclosure of the study information 2016/01/04
Last modified on 2020/01/10

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Basic information
Public title Study of Luseogliflozin against hypertension merger diabetes patients
Acronym Study of Luseogliflozin against hypertension merger diabetes patients
Scientific Title Study of Luseogliflozin against hypertension merger diabetes patients
Scientific Title:Acronym Study of Luseogliflozin against hypertension merger diabetes patients
Region
Japan

Condition
Condition Type2 Diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The efficiency and safety of Luseogliflozin for Japanese type 2 diabetes patients complicated with hypertension.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes HbA1c
24-hour blood pressure (24-hour average blood pressure, daytime average blood pressure, night time average blood pressure)
Outpatient blood pressure (systolic blood pressure, diastolic blood pressure)
Key secondary outcomes Fasting blood glucose
Fasting insulin
Fasting C-peptide
Fasting glucagon
HOMA-IR
HOMA-beta
iHOMA2
Plasma renin activity
Aldosterone concentration
Adrenaline
Noradrenaline
Dopamine
Angiotensin 2
TG
TC
LDL-C
HDL-C
non-HDL-C
Free fatty acid
Adiponectin
Uric acid
Body weight
Waist
Amount of body fat mass
Amount of Lean fat mass
Intracellular water content
Extracellular water content
Body water content
Protein mass
Muscle mass
Mineral content
NO
High sensitivity CRP
Urinary protein (quantitative)
Urinary creatinine
Urinary sugar
Urine sodium
Urinary chlorine
Urinary albmin
Mean arterial pressure
Pulse pressure
Double product
SD and CV of blood pressure in each period of 24-hour, daytime, nighttime
Target value achievement rate of 24 hours, daytime nighttime blood pressure values after administration 12 weeks
Improvement rate of nighttime hypertension
Systolic blood pressure and diastolic blood pressure in Non-dipper type patient and Dipper-type patients
Improvement rate of early morning hypertension
Systolic blood pressure and diastolic blood pressure in early morning hypertension patients
Improvement rate of morning surge
Ambulatory arterial stiffness index
Hyperbaric area
Trough/Peak
Smoothness Index

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 Luseogliflozin
Dosing period : 12 weeks
Dose : 2.5mg/day(1 tablet per 1 day)
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 Document consent has been obtained for participation in this study
Type 2 Diabetes
Age >20
HbA1c 6.5-10.5 %
BMI >22 kg/m2
Hypertension that meets one of the following criteria
SBP >130mmHg
Using antihypertensive agents (including diuretics)
Not taking the diabetes medicine or the oral hypoglycemic medicine from 1 to 3 who are to continue taking the same drug and the same dose (SGLT2 inhibitors except)
Continued a certain diet
Key exclusion criteria The patients who had another type of type 2 diabetes
Secondary hypertension
SBP > 180mmHg or DBP >110mmHg
Have a medical history of cardiovascular events
Have a severe kidney disease or a severe liver disease
Have a the malignant tumor, or those who have a medical history of malignant tumor
Taking SGLT2 inhibitor within 12 weeks before the start of administration
Patients with contraindication of Luseogliflozin
Considered as inappropriate by the investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Shinichiro
Middle name
Last name Shirabe
Organization Medical Corporation
H.E.C Science Clinic
Division name Diabetes internal medicine
Zip code 235-0045
Address 4-1-4-102 Youkoudai Isogo-ku Yokohama-city Kanagawa-ken Japan
TEL 045-831-0031
Email hec@asahi-net.email.ne.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Makuuchi
Organization Medical Corporation H.E.C Science Clinic
Division name Clinical Trial Secretariat
Zip code 235-0045
Address 4-1-4-102 Youkoudai Isogo-ku Yokohama-city Kanagawa-ken Japan
TEL 045-831-0031
Homepage URL
Email hec@asahi-net.email.ne.jp

Sponsor
Institute Medical Corporation H.E.C Science Clinic
Institute
Department

Funding Source
Organization Taisho Toyama Pharmaceutical Co. ,Ltd.
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 Ethics review committee of Medical Corporation H.E.C Science Clinic
Address 4-1-4-102 Youkoudai Isogo-ku Yokohama-city Kanagawa-ken Japan
Tel 045-831-0031
Email hec-soum@asahi-net.email.ne.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 医療法人社団一洋会 H.E.Cサイエンスクリニック(神奈川県)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 04 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
2015 Year 12 Month 08 Day
Date of IRB
2015 Year 12 Month 09 Day
Anticipated trial start date
2016 Year 01 Month 04 Day
Last follow-up date
2017 Year 08 Month 31 Day
Date of closure to data entry
2017 Year 09 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 04 Day
Last modified on
2020 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023590

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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