UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022580 |
|---|---|
| Receipt number | R000026024 |
| Scientific Title | Tofogliflozin Reduces 24-h Ambulatory Blood Pressure in inpatients with Type 2 Diabetes and Hypertension |
| Date of disclosure of the study information | 2016/06/15 |
| Last modified on | 2018/03/12 08:54:04 |
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Basic information
Public title
Tofogliflozin Reduces 24-h Ambulatory Blood Pressure in inpatients with Type 2 Diabetes and Hypertension
Acronym
The Influence of Tofogliflozin on 24-h Ambulatory Blood Pressure
Scientific Title
Tofogliflozin Reduces 24-h Ambulatory Blood Pressure in inpatients with Type 2 Diabetes and Hypertension
Scientific Title:Acronym
The Influence of Tofogliflozin on 24-h Ambulatory Blood Pressure
Region
| Japan |
Condition
Condition
Type 2 diabetes with hypertension
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
SGLT-2 inhibitors lead to reduced systolic and diastolic blood pressure inpatients with type 2 diabetes.
We investigated the efficacy and influence of tofogliflozin on 24h-blood pressure using 24-h Ambulatory Blood Pressure Monitoringin inpatinets with type 2 diabetes and hypertension.
We also performed power spectrum analysis of heart rate variability before and after the administration of tofogliflozin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
24h-blood pressure(systolic and diastolic)
before and after the administration of 20mg tofogliflozin.
Key secondary outcomes
Holter electrocardiograph,power spectrum analysis,NT-proBNP and D-ROMs before and after the administration of tofogliflozin.
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
ABPM was performed twice time at pretreatmentand posttreatment for 1week of tofogliflozin.
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
1)patient with type 2 diabetesand hypertension doing a hospitalizing for diabetes treatment
2)Patients treated with Angiotensin Receptor Blocker(ARB) and/or Angiotensin Converting Enzyme Inhibitors(ACE-I) for hypertension
3) SBP>140mmHg and/or DBP>90mmHg
Key exclusion criteria
1) Type 1 diabetes
2) Severe diabetic complications such as ketoacidosis
3) Severe renal dysfunction(estimated glomerular filtration rate [eGFR] < 30 mL/min/)
4) Pregnant or nursing women and those who might be pregnant
5) Chronic heart failure,
6) Haemodialysis,
7) A history of stroke and cardiovascular events,
8) Any patient whom the investigator judged to be inappropriate for this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimasa Aso |
Organization
Dokkyo Medical University
Division name
Endocrinology and Metabolism
Zip code
Address
880, Kitakobayashi, Mibu, Shimotsugagun, Tochigi
TEL
0282-87-2150
yaso@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunihiro Suzuki |
Organization
Dokkyo Medical University
Division name
Endocrinology and Metabolism
Zip code
Address
880, Kitakobayashi, Mibu, Shimotsugagun, Tochigi
TEL
0282-87-2150
Homepage URL
kuni-s@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 15 | 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
| 2016 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 02 | Day |
Last modified on
| 2018 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026024
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
