Unique ID issued by UMIN | UMIN000006990 |
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Receipt number | R000008248 |
Scientific Title | Long-term Insulin vs Liraglutide Effect on Beta-cell Function in Type 1 Diabetes with Residual Insulin Secretion-Extension Study |
Date of disclosure of the study information | 2011/12/30 |
Last modified on | 2017/07/04 11:12:03 |
Long-term Insulin vs Liraglutide Effect on Beta-cell Function in Type 1 Diabetes with Residual Insulin Secretion-Extension Study
SAVE-ISLET Extension Study
Long-term Insulin vs Liraglutide Effect on Beta-cell Function in Type 1 Diabetes with Residual Insulin Secretion-Extension Study
SAVE-ISLET Extension Study
Japan |
Type 1 diabetes with residual insulin secretion (Slowly Progressive Insulin-Dependent Diabetes millitus, Latent Autoimmune Diabetes in Adults)
Endocrinology and Metabolism |
Others
NO
This study is to investigate the effect of liraglutide, an once-daily injection long-acting GLP-1 receptor agonist, on beta-cell mass and function as well as glycemic control in patients with type 1 diabetes with residual insulin secretion.
Safety,Efficacy
Exploratory
Changes in insulin secretory response to glucagon- and arginine-stimulation test
Anti GADAb, Glycemic control(HbA1c, FPG/PPG, 7 points blood glucose levels in self-monitoring of blood glucose, Body weight, Hypoglycemia, Total dose of insulin injection per day, Adverse Events (including an abnormal laboratory finding)
Interventional
expanded access
Non-randomized
Open -no one is blinded
Historical
2
Treatment
Medicine |
Liraglutide group
Continuous administration of Liraglutide injection 0.6-0.9mg per day on insulin therapy for 52 weeks
(Totally 108 weeks)
Liraglutide group
Insulin group
Additional administration of Liraglutide injection 0.6-0.9mg per day on ongoing insulin therapy for 52 weeks
20 | years-old | <= |
Not applicable |
Male and Female
1. The patients who have agreed to participate in this study with an informed consent
2. The patients who have finished the previous study
1. The patients who did not agree with this study
2. The patients who was observed a serious complication in previous study
3. Those who are not approved to be eligible to this study by corresponding researcher or co-researchers
20
1st name | |
Middle name | |
Last name | Yoshiyuki Hamamoto |
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Center for Diabetes and Endocrinology
2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN
06-6312-1221
1st name | |
Middle name | |
Last name |
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Center for Diabetes and Endocrinology
2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN
06-6312-1221
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Self funding
NO
公益財団法人 田附興風会医学研究所 北野病院(大阪府)
2011 | Year | 12 | Month | 30 | Day |
Unpublished
Completed
2011 | Year | 12 | Month | 26 | Day |
2011 | Year | 12 | Month | 27 | Day |
2015 | Year | 08 | Month | 31 | Day |
2015 | Year | 10 | Month | 01 | Day |
2015 | Year | 10 | Month | 01 | Day |
2017 | Year | 10 | Month | 01 | Day |
2011 | Year | 12 | Month | 30 | Day |
2017 | Year | 07 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008248
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