Unique ID issued by UMIN | UMIN000017144 |
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Receipt number | 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 21:59:28 |
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.
Effects of long and short acting GLP-1 agonists on diabetic cardiovascular neuropathy and glycemic fluctuations. ELABORATE
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.
Effects of long and short acting GLP-1 agonists on diabetic cardiovascular neuropathy and glycemic fluctuations. ELABORATE
Japan |
Type 2 diabetes
Medicine in general | Endocrinology and Metabolism |
Others
NO
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.
Safety,Efficacy
Confirmatory
Explanatory
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
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Numbered container method
2
Treatment
Medicine |
Liraglutide group
Lixisenatide group
20 | years-old | <= |
80 | years-old | > |
Male and Female
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
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
30
1st name | |
Middle name | |
Last name | Yosimasa Aso |
Dokkyo Medical University
Department of Endocrinology and Metabolism
880Kita-kobayashi,Mibu,Tochigi321-0293,Japan
0282-87-2150
yaso@dokkyomed.ac.jp
1st name | |
Middle name | |
Last name | Takanori Tomotsune |
Dokkyo Medical University
Department of Endocrinology and Metabolism
880Kita-kobayashi,Mibu,Tochigi321-0293,Japan
0282-87-2150
tomotsu@dokkyomed.ac.jp
Department of Endocrinology and Metabolism, Dokkyo Medical University
none
Self funding
NO
2015 | Year | 05 | Month | 01 | Day |
Unpublished
Open public recruiting
2015 | Year | 03 | Month | 30 | Day |
2015 | Year | 05 | Month | 01 | Day |
2015 | Year | 04 | Month | 15 | Day |
2016 | Year | 04 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019723
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