UMIN-CTR Clinical Trial

Public title

Japanese study of Linagliptin for type 2 diabetes patients with NAFLD in Kagoshima

Acronym

J-LINK study

Scientific Title

Japanese study of Linagliptin for type 2 diabetes patients with NAFLD in Kagoshima

Scientific Title:Acronym

J-LINK study

Region

Japan

Condition

Type 2 Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

1. To evaluate the effects of improved fatty liver of type 2 Diabetes with NAFLD, nonalcoholic fatty liver disease by comparing a Linagliptin group and a metformin increasing group.
2. To evaluate the safety of Linagliptin.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Changes of fat amount and means in the liver at 52 weeks from baseline measured with computer technology

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A group of increasing metformin up to 1500mg

Interventions/Control_2

A group of add-on Linagliptin

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

75

years-old

>

Gender

Male and Female

Key inclusion criteria

Only those meet the following criteria will be qualified for this study;
Inclusion Criteria:
1.Type 2 Diabetes with HbA1c (NGSP) 6.0% or higher and below 8.5%
2.NAFLD (Bright liver found with ultrasonic examination and AST or ALT is twice higher or greater than normal ranges, which differ from hospital to hospital)
3.PT-INR International normalized ratio< 1.7, ALB> 3.5g/dL,
TB< 1.5mg/dL
4.eGFR is 50mL/min/1.73m&sup2; or higher
5.Has no previous metformin experience, or has metformin 750mg or less per day without other medicine for diabetes at screening
6.Alcohol intake: No excess of 20g per day for men and 10g per day for women
7. Men or women aged 20 to 74
8. 18< BMI< 35
9. Agree with diet therapy before and during the experiment

Key exclusion criteria

Person who correspond to any of following will be excluded;
Exclusion Criteria;
1.Type1 diabetes or secondary diabetes
2.Current use of warfarin potassium
3.Hepatitis B surface antigen positive or HCV antibody positive
4.Has severe injury, severe infection or an operation scheduled within one year
5.MI, AP, or CI in 12 weeks before obtaining informed consent
6.Atrial fibrillation or frequent ventricular ectopy
7.Moderate or greater cardiac insufficiency ,stage 3 or higher of New York Heart Association classification.
8.AST or ALT is 5 times higher or greater than normal values ,values differ among the hospitals
9.Alpha1 antitrypsin deficiency,Wilson's disease,primary biliary cirrhosis(PBC),or serum creatinine is twice higher than normal values
10.Ascites, encephalopathia
11.Possible labile hypertension or instability lipid abnormality found twelve weeks before obtaining informed consent
12.Alcohol or drug addiction
13.Pregnant, breast feeding, or possible pregnancy
14.Anyone who falls into contraindicated conditions
15.Any condition that may raise doctor concern

Target sample size

48

Name of lead principal investigator

1st name
Middle name
Last name	Tetsuro Kamada

Organization

Public Interest Incorporated Foundation Jiaikai Imamura Hospital

Division name

Diabetes Center

Zip code

Address

Horiecho17-1,Kagoshima-city,Kagoshima,Japan

TEL

099-226-2600

Email

tkamada@jiaikai.jp

Name of contact person

1st name
Middle name
Last name	Hiroki Takayama

Organization

Soiken Inc.

Division name

Division of clinical study support

Zip code

Address

NFB Ogawa-cho Bldg 4F, 1-3-1, Kanda Ogawa-cho, Chiyoda-ku, Tokyo

TEL

03-3295-1350

Homepage URL

Email

takayama@soiken.com

Institute

Japan society of Patient Reported Outcome

Institute

Department

Personal name

Organization

Nippon Boehringer Ingelheim Co., Ltd.
Eli Lilly Japan K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

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

Date of disclosure of the study information

2014

Year

08

Month

15

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

2014

Year

07

Month

22

Day

Date of IRB

Anticipated trial start date

2014

Year

09

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

08

Month

14

Day

Last modified on

2019

Year

03

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017278