UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020427 |
|---|---|
| Receipt number | 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 14:36:04 |
* 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
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
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
hec@asahi-net.email.ne.jp
Sponsor or person
Institute
Medical Corporation H.E.C Science Clinic
Institute
Department
Personal name
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
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
Value
https://center6.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 |
