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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030622
Receipt No. R000034951
Scientific Title Effects of liraglutide add-on to insulin therapy in patients with type 2 diabetes
Date of disclosure of the study information 2017/12/29
Last modified on 2019/02/18

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Basic information
Public title Effects of liraglutide add-on to insulin therapy in patients with type 2 diabetes
Acronym Effects of liraglutide add-on to insulin therapy in patients with type 2 diabetes
Scientific Title Effects of liraglutide add-on to insulin therapy in patients with type 2 diabetes
Scientific Title:Acronym Effects of liraglutide add-on to insulin therapy in patients with type 2 diabetes
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to verify the effect of GLP-1 receptor agonist liraglutide on glucose metabolism in patients with type 2 diabetes,who have inadequate glycemic control despite insulin therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in HbA1c over the 48-week treatment period.
Key secondary outcomes Fasting plasma glucose(mg/dL),Glycated albumin(%)
Body weight(kg),Body mass index(BMI)
Insulin dose(units/day)
CPR-index,HOMA2-%beta(%)
HOMA2-IR
Urine albumin/creatinine ratio(mg/gCr)
Systolic blood pressure(mmHg),Diastolic blood pressure(mmHg),Pulse rate
Lipid profile
UA(mg/dL)
AST,ALT,gamma-GTP
BUN(mg/dL),Serum creatinine(mg/dL),eGFR (ml/min/1.73m2),cystatinC(mg/L)
Hypoglicemic events
Other adverse events

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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with type 2 diabetes who fulfilled the following criteria.

(1)Aged 20 and over;At the time of the initiation of insulin and liraglutide combination therapy (in outpatients)
(2)The patients with insulin (in outpatients)
Undergoing diagnosis of type 2 diabetes
(3)Glycemic control;7.0 % <=HbA1c
(4)The use content of existing oral medicine and insulin does not matter.
Last Observation Carried Forward(LOCF) is applied in the following cases.
Receiving an additional oral anti-diabetes drug or increasing the amount of use of oral anti-diabetes drug within 48 weeks after initiation of insulin and liraglutide combination therapy.
(5)The patients who undergo a necessary testing item on analyzing this study

Key exclusion criteria (1)Liraglutide induction by educational hospitalization of diabetes
(2)Renal dysfunction (eGFR <30ml/min/1.73m2)
(3)Steroid medication
(4)Liver cirrhosis merger
(5)Active Malignant neoplasm
(6)Pregnant or lactating women
(7)Decided as inappropriate for participating in this study by physician
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Terauchi
Organization Yokohama City University Graduate School of Medicine
Division name Department of Endocrinology and Metabolism
Zip code
Address 3-9 Fukuura,Kanazawa-ku,Yokohama,Kanagawa
TEL 045-787-2639
Email terauchi@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirotatsu Nakaguchi
Organization Yokohama City University Graduate School of Medicine
Division name Department of Endocrinology and Metabolism
Zip code
Address 3-9 Fukuura,Kanazawa-ku,Yokohama,Kanagawa
TEL 045-787-2639
Homepage URL
Email t156054d@yokohama-cu.a.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Japan Community Health care Organization,Yokohama Central Hospital
Chigasaki Municipal Hospital
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 横浜市立大学附属病院(神奈川県) Yokohama City University Hospital(kanagawa)
地域医療機能推進機構 横浜中央病院(神奈川県) Japan Community Health care Organization,Yokohama Central Hospital(kanagawa)
茅ケ崎市立病院(神奈川県) Chigasaki Municipal Hospital(kanagawa)


Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 29 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 Completed
Date of protocol fixation
2017 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information a retrospective observational study using the existing information

Management information
Registered date
2017 Year 12 Month 28 Day
Last modified on
2019 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034951

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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