UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029194 |
|---|---|
| Receipt number | 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 | 2020/10/21 09:49:16 |
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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 | 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
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
hmotoki@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033375
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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