UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the effect of empagliflozin on cardiac sympathetic and parasympathetic nerve activity in Japanese patients with type 2 diabetes
Acronym	EMPYREAN study
Scientific Title	Investigation of the effect of empagliflozin on cardiac sympathetic and parasympathetic nerve activity in Japanese patients with type 2 diabetes
Scientific Title:Acronym	EMPYREAN study
Region	Japan

Condition
Condition	Diabetes Mellitus (type 2)
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of empagliflozin on cardiac autonomic nervous activity
Basic objectives2	Others
Basic objectives -Others	To estimate changes from the baseline in LF, HF, and LF/HF ratio, 24 weeks after the empagliflozin administration
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes from the baseline in LF, HF, and LF/HF ratio at the 24 weeks after the treatment. LF and HF will be estimated by heart rate valiability from 24-hour Holer ECG dataset, calcurated by spectral analysis.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Empagliflozin 10mg qD will be administrated in group EMPA. Empagliflozin could be used upto 25mg qD during 12-24 weeks after the administration.
Interventions/Control_2	Sitagliptin 50mg qD will be administrated in group SITA. Sitagliptin could be used upto 100mg qD during 12-24 weeks after the administration.
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	1) DM Patients with 7.0%<HbA1c<10% under the conventional diet/exercise therapy 2) Patients treated without SGLT-2 or DPP-4 within 12 weeks
Key exclusion criteria	1) Patients treated with insulin or GLP-1 analogue 2) Patients with eGFR<45mL/min/1.73m2 3) Patients with Afib 4) Patients implanted PM 5) Patients who treated with beta-blockers, alpha-blokers, Digoxis, and CCB.
Target sample size	134

Research contact person
Name of lead principal investigator	1st name Koichiro Middle name Last name Kuwahara
Organization	Shinshu University School of Medicine
Division name	Department of Cardiovascular Medicine
Zip code	3908621
Address	Asahi 3-1-1, Matsumoto
TEL	0263-37-3486
Email	kkuwa@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Hirohiko Middle name Last name Motoki
Organization	Shinshu University School of Medicine
Division name	Department of Cardiovascular Medicine
Zip code	3908621
Address	Asahi 3-1-1, Matsumoto
TEL	0263-37-3486
Homepage URL
Email	hmotoki@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University School of Medicine
Institute
Department

Funding Source
Organization	Boehringer Ingelheim Seiyaku. Eli Lilly and Company.
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	Shinshu University Hospital Institutional Review Board
Address	Asahi 3-1-1, Matsumoto
Tel	0263-35-4600
Email	mdrinri@shinshu-u.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

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 19 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	112
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	No longer recruiting
Date of protocol fixation	2017 Year 09 Month 05 Day
Date of IRB	2017 Year 09 Month 05 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date	2020 Year 12 Month 25 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 09 Month 19 Day
Last modified on	2020 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033375