UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Empagliflozin on Ambulatory Blood Pressure Monitoring (ABPM)
Title of the study (Brief title)	Effect of Empagliflozin on ABPM
Region	Japan

Condition
Condition	Diabetics Mellitus Hypertension
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of Empagliflozin on 24 hour blood pressure changes by using ABPM
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change of 24 hour blood pressure
Key secondary outcomes	Changes of fast blood glucose and HbA1c Change of renal function

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Empagliflozin
Interventions/Control_2	DPP4 Inhibitor
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with DM and Hypertension
Key exclusion criteria	eGFR<30ml/min/1.73m2 Liver Dysfunction
Target sample size	20

Research contact person
Name of lead principal investigator	Hidetomo Nakamoto
Organization	Saitama Medical University
Division name	Department of General Internal Medicine
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL	049-276-1667
Email	nakamo_h@saitama-med.ac.jp

Public contact
Name of contact person	Hidetomo Nakamoto
Organization	Saitama Medical University
Division name	Department of General Internal Medicine
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL	049-276-1667
Homepage URL
Email	nakamo_h@saitama-med.ac.jp

Sponsor
Institute	Department of General Internal Medicine, Saitama Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Department of Internal Medicine, Saitama Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	埼玉医科大学病院

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date	2016 Year 12 Month 01 Day
Date of closure to data entry	2017 Year 04 Month 30 Day
Date trial data considered complete	2017 Year 06 Month 30 Day
Date analysis concluded	2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 27 Day
Last modified on	2016 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025487