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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000013191
Receipt No. R000015384
Scientific Title Influence of linagliptin (DPP-4 inhibitor) on heart autonomic nervous system, heart function and visceral fat area
Date of disclosure of the study information 2014/02/20
Last modified on 2016/09/19

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Basic information
Public title Influence of linagliptin (DPP-4 inhibitor) on heart autonomic nervous system, heart function and visceral fat area
Acronym Influence of linagliptin (DPP-4 inhibitor) on heart autonomic nervous system, heart function and visceral fat area
Scientific Title Influence of linagliptin (DPP-4 inhibitor) on heart autonomic nervous system, heart function and visceral fat area
Scientific Title:Acronym Influence of linagliptin (DPP-4 inhibitor) on heart autonomic nervous system, heart function and visceral fat area
Region
Japan

Condition
Condition Type 2 diabetes mellitus.
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess heart autonomic nervous system, ECG variability and QTc variability using the heart rate variability and visceral fat variability of linagliptin for type 2 diabetes mellitus.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change of ECG (Heart rate variability, QT variability) and visceral fat area and subcutaneous fat area by BIA from baseline (Visit 0) to 12 and 24 weeks.
Key secondary outcomes

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 DPP-4 inhibitor (linagliptin)
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)Type 2 diabetic patients (HbA1c(NGSP value),higher than 6.5% but lower than 9.0%)
2) Patients who can begin treatment linagliptin this study, but patients who had taken other DPP-4 inhibitor. (Not washout period)
3) Patients who are stably treating with lipid-lowering drugs or Anti-hypertension drugs
4) Age,20-80(Male and female)
5) Written informed consent are taken for the enrollment
Key exclusion criteria 1)Type 2 diabetic patients (HbA1c(NGSP value),higher than 6.5% but lower than 9.0%)
2) Patients who can begin treatment linagliptin this study, but patients who had taken other DPP-4 inhibitor. (Not washout period)
3) Patients who are stably treating with lipid-lowering drugs or Anti-hypertension drugs
4) Age,20-80(Male and female)
5) Written informed consent are taken for the enrollment
1) Patients who are Type I or Secondary diabetic mellitus
2) Patients who are treating with GLP-1 agonist or Thiazolidinedione at the time of study initiation
3) Patients who are severe infectious disease, perioperative, and severe trauma
4)Patients with myocardial infarction, angina pectoris, cerebral stroke, or cerebral infarction
5) Patients with moderate or severer heart failure (NYHA/New York Heart Association stage 3 or severer)
6) Patients who are pregnant, lactating, and possibly pregnant women and those planning to become pregnant
7) Patients with a history of hypersensitivity to investigational drugs
8) Patients with cancer
9) Patients who receive steroid therapy with inflammatory affection
10) Patients whom doctor judges as ineligible to this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Izuru Masuda
Organization Takeda Hospital
Division name Medical Examination Center
Zip code
Address 3F, Nihonseimei Kyoto Santetsu Bldg 608 Higashi-Shiokoji-cho, Shimogyoku, Kyoto, Japan
TEL 075-365-0825
Email imasuda@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Izuru Masuda
Organization Takeda Hospital
Division name Medical Examination Center
Zip code
Address 3F, Nihonseimei Kyoto Santetsu Bldg 608 Higashi-Shiokoji-cho, Shimogyoku, Kyoto, Japan
TEL 075-365-0825
Homepage URL
Email imasuda@kuhp.kyoto-u.ac.jp

Sponsor
Institute Takeda Hospital Medical Examination Center
Institute
Department

Funding Source
Organization Japan Vascular Disease Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
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
2014 Year 02 Month 20 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 Preinitiation
Date of protocol fixation
2013 Year 11 Month 29 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 20 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
2014 Year 02 Month 18 Day
Last modified on
2016 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=R000015384

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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