UMIN-CTR Clinical Trial

Basic information
Public title	Effect of the combination therapy of liraglutide, a GLP-1 receptor analog, and IDegAsp in patients with type 2 diabetes
Acronym	Effect of the combination therapy of liraglutide, a GLP-1 receptor analog, and IDegAsp
Scientific Title	Effect of the combination therapy of liraglutide, a GLP-1 receptor analog, and IDegAsp in patients with type 2 diabetes
Scientific Title:Acronym	Effect of the combination therapy of liraglutide, a GLP-1 receptor analog, and IDegAsp
Region	Japan

Condition
Condition	Type2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For type2 diabetes patients with insufficient control, to examine the improvement of the quality of life (QOL) and the glycemic effect, as basal insulin was switched to IDegAsp with changing from DPP-4 inhibitor to Liraglutide.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change in QOL scores from baseline to 3 months in patients with switched therapy to Liraglutide/IDegAsp.
Key secondary outcomes	Difference of change in HbA1c, body weight, units of insulin dose, frequency of hypoglycemia (SMBG), SD and CV % of FPG on SMBG, clinical and laboratory parameters

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients with type 2 diabetes treated with basal insulin and DPP-4 inhibitor. 2)HbA1c>7.5% 3)Patients who can respond to questionnaire survey. 4)Patients who gave written informed consent.
Key exclusion criteria	1)Patients with severe renal dysfunction including patients requiring hemodialysis or peritoneal dialysis(eGFR<30ml/min). 2)pregnant 3)Patients who have severe diabetic ketosis, diabetic coma. 4)Patients with severe infection, severe injury or perioperative state.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Tadashi Middle name Last name Yamakawa
Organization	Yokohama City University Medical Center
Division name	Department of Endocrinology and Diabetes
Zip code	232-0024
Address	4-57 Urafune-cho, Mimami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	naibunpi@urahp.yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Marina Middle name Last name Harada
Organization	Yokohama City University Medical Center
Division name	Department of Endocrinology and Diabetes
Zip code	232-0024
Address	4-57 Urafune-cho, Mimami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	onyogora@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center Department of Endocrinology and Diabetes
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	Medical Ethics Committee for Humans
Address	3-9 FukuuraKanazawa-ku, Yokohama City, Japan
Tel	0453707627
Email	rinri@yokohama-cu.ac.jp

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	横浜市立大学附属市民総合医療センター 浦舟金沢内科クリニック

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 26 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	Terminated
Date of protocol fixation	2017 Year 08 Month 23 Day
Date of IRB	2017 Year 03 Month 29 Day
Anticipated trial start date	2017 Year 08 Month 24 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study based on the questionnaire Diabetes therapy Related QOL(DTR-QOL) Problem areas in diabetes survey (PAID)

Management information
Registered date	2018 Year 07 Month 25 Day
Last modified on	2021 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038212