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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017144
Receipt No. R000019723
Scientific Title Comparing effects of a long acting GLP-1 receptor agonist liraglutide with a short acting GLP-1 receptor agonist lixisenatide on diabetic cardiac autonomic neuropathy and glycemic variability evaluated by power spectral analysis of 24-hr heart rate and continuous glucose monitoring.
Date of disclosure of the study information 2015/05/01
Last modified on 2016/04/27

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Basic information
Public title Comparing effects of a long acting GLP-1 receptor agonist liraglutide with a short acting GLP-1 receptor agonist lixisenatide on diabetic cardiac autonomic neuropathy and glycemic variability evaluated by power spectral analysis of 24-hr heart rate and continuous glucose monitoring.
Acronym Effects of long and short acting GLP-1 agonists on diabetic cardiovascular neuropathy and glycemic fluctuations. ELABORATE
Scientific Title Comparing effects of a long acting GLP-1 receptor agonist liraglutide with a short acting GLP-1 receptor agonist lixisenatide on diabetic cardiac autonomic neuropathy and glycemic variability evaluated by power spectral analysis of 24-hr heart rate and continuous glucose monitoring.
Scientific Title:Acronym Effects of long and short acting GLP-1 agonists on diabetic cardiovascular neuropathy and glycemic fluctuations. ELABORATE
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compare a long acting GLP-1 receptor agonist liraglutide with a short acting GLP-1receptor effects on diabetic cardiovascular autonomic neuropathy and glycemic variability in patients with type 2 diabetes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes Differences in 24-hr glycemic variability using continuous glucose monitoring systems ,
Differences in 24-hr heart rate variability evaluated by power spectral analysis
Differences in 24-hr mean heart rate
Key secondary outcomes 24-hour blood pressure variability
Gastric emptying rate by an acetaminophen loading test
Orthostatic hypotension by Schellong test
Plasma levels of A- and B-type natriuretic peptide (ANP and BNP)
Serum 1, 5 anhidroglucitol (1, 5-AG)
Safety evaluation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Liraglutide group
Interventions/Control_2 Lixisenatide group
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 diabetes who have inadequate glycemic control(HbA1c between 7.0 and 12.4 %) under medical treatment by dieting and exercise cure and/or drug treatment.
2)Over 20 years old and less than 80 years old
3)Sex unquestioned
4)Patients with no history of cardiovascular disease
5)No treatment or treatment with stable doses of antihypertensive and antiplatelet agents for at least 3 months prior to randomization.
6)The patient who gives a written informed
Key exclusion criteria 1)Type 1 diabetes
2)Liver dysfunction (hepatic enzymes more than three times the upper limit of normal ranges)
3)A pregnant woman and/or a woman under breast-feeding
4)Impaired kidney function (serum crearinine greater than 1.3 mg/dl in men, 1.2 mg/dl in women)
5)Diabetic proliferative retinopathy
6)The patients who has an anamnesis of hypersensitivity to the ingredient of a trial drug
7)Cigarette smokers
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yosimasa Aso
Organization Dokkyo Medical University
Division name Department of Endocrinology and Metabolism
Zip code
Address 880Kita-kobayashi,Mibu,Tochigi321-0293,Japan
TEL 0282-87-2150
Email yaso@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takanori Tomotsune
Organization Dokkyo Medical University
Division name Department of Endocrinology and Metabolism
Zip code
Address 880Kita-kobayashi,Mibu,Tochigi321-0293,Japan
TEL 0282-87-2150
Homepage URL
Email tomotsu@dokkyomed.ac.jp

Sponsor
Institute Department of Endocrinology and Metabolism, Dokkyo Medical University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 05 Month 01 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
2015 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 05 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
2015 Year 04 Month 15 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=R000019723

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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