UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Long-term Insulin vs Liraglutide Effect on Beta-cell Function in Type 1 Diabetes with Residual Insulin Secretion-Extension Study
Title of the study (Brief title)	SAVE-ISLET Extension Study
Region	Japan

Condition
Condition	Type 1 diabetes with residual insulin secretion (Slowly Progressive Insulin-Dependent Diabetes millitus, Latent Autoimmune Diabetes in Adults)
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in insulin secretory response to glucagon- and arginine-stimulation test
Key secondary outcomes	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)

Base
Study type	Interventional

Study design
Basic design	expanded access
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Liraglutide group Continuous administration of Liraglutide injection 0.6-0.9mg per day on insulin therapy for 52 weeks (Totally 108 weeks)
Interventions/Control_2	Liraglutide group Insulin group Additional administration of Liraglutide injection 0.6-0.9mg per day on ongoing insulin therapy for 52 weeks
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. The patients who have agreed to participate in this study with an informed consent 2. The patients who have finished the previous study
Key exclusion criteria	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
Target sample size	20

Research contact person
Name of lead principal investigator	Yoshiyuki Hamamoto
Organization	Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name	Center for Diabetes and Endocrinology
Address	2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN
TEL	06-6312-1221
Email

Public contact
Name of contact person
Organization	Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name	Center for Diabetes and Endocrinology
Address	2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN
TEL	06-6312-1221
Homepage URL
Email

Sponsor
Institute	Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Institute
Department

Funding Source
Organization	Kitano Hospital, The Tazuke Kofukai Medical Research Institute
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	公益財団法人　田附興風会医学研究所　北野病院(大阪府)

Other administrative information
Date of disclosure of the study information	2011 Year 12 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 26 Day
Anticipated trial start date	2011 Year 12 Month 27 Day
Last follow-up date	2015 Year 08 Month 31 Day
Date of closure to data entry	2015 Year 10 Month 01 Day
Date trial data considered complete	2015 Year 10 Month 01 Day
Date analysis concluded	2017 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 12 Month 30 Day
Last modified on	2017 Year 07 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008248