UMIN-CTR Clinical Trial

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

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Yokohama City University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Japan Community Health care Organization,Yokohama Central Hospital
Chigasaki Municipal Hospital

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2017

Year

12

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

a retrospective observational study using the existing information

Registered date

2017

Year

12

Month

28

Day

Last modified on

2019

Year

02

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034951