UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of liraglutide add-on to insulin therapy in patients with type 2 diabetes
Title of the study (Brief title)	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	Yasuo Terauchi
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Endocrinology and Metabolism
Address	3-9 Fukuura,Kanazawa-ku,Yokohama,Kanagawa
TEL	045-787-2639
Email	terauchi@yokohama-cu.ac.jp

Public contact
Name of contact person	Hirotatsu Nakaguchi
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Endocrinology and Metabolism
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 25 Day
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

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Publication of results	Unpublished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