UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yosimasa Aso
Organization	Dokkyo Medical University
Division name	Department of Endocrinology and Metabolism
Address	880Kita-kobayashi,Mibu,Tochigi321-0293,Japan
TEL	0282-87-2150
Email	yaso@dokkyomed.ac.jp

Public contact
Name of contact person	Takanori Tomotsune
Organization	Dokkyo Medical University
Division name	Department of Endocrinology and Metabolism
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 03 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019723