UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japanese study of Linagliptin for type 2 diabetes patients with NAFLD in Kagoshima
Title of the study (Brief title)	J-LINK study
Region	Japan

Condition
Condition	Type 2 Diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	Changes of fat amount and means in the liver at 52 weeks from baseline measured with computer technology
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Tetsuro Kamada
Organization	Public Interest Incorporated Foundation Jiaikai Imamura Hospital
Division name	Diabetes Center
Address	Horiecho17-1,Kagoshima-city,Kagoshima,Japan
TEL	099-226-2600
Email	tkamada@jiaikai.jp

Public contact
Name of contact person	Hiroki Takayama
Organization	Soiken Inc.
Division name	Division of clinical study support
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

Sponsor
Institute	Japan society of Patient Reported Outcome
Institute
Department

Funding Source
Organization	Nippon Boehringer Ingelheim Co., Ltd. Eli Lilly Japan K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 22 Day
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

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Publication of results	Unpublished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

Management information
Registered date	2014 Year 08 Month 14 Day
Last modified on	2019 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017278