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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033511
Receipt No. R000038212
Scientific Title Effect of the combination therapy of liraglutide, a GLP-1 receptor analog, and IDegAsp in patients with type 2 diabetes
Date of disclosure of the study information 2018/07/26
Last modified on 2018/07/25

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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
Middle name
Last name Tadashi Yamakawa
Organization Yokohama City University Medical Center
Division name Department of Endocrinology and Diabetes
Zip code
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
Middle name
Last name Marina Harada
Organization Yokohama City University Medical Center
Division name Department of Endocrinology and Diabetes
Zip code
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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 24 Day
Last follow-up date
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
2018 Year 07 Month 25 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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