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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029194
Receipt No. R000033375
Scientific Title Investigation of the effect of empagliflozin on cardiac sympathetic and parasympathetic nerve activity in Japanese patients with type 2 diabetes
Date of disclosure of the study information 2017/09/19
Last modified on 2017/09/19

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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
Middle name
Last name Koichiro Kuwahara
Organization Shinshu University School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address Asahi 3-1-1, Matsumoto
TEL 0263-37-3486
Email kkuwa@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirohiko Motoki
Organization Shinshu University School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
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
Address
Tel
Email

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
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 Open public recruiting
Date of protocol fixation
2017 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
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
2017 Year 09 Month 19 Day


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

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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