UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Randomized study of Linagliptin effectiveness for Endothelial function by using FMD
Title of the study (Brief title)	Relief study
Region	Japan

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

Objectives
Narrative objectives1	The purposes of this study is to examine the linagliptin effectiveness for endothelial function by using FMD and using CAVI, compared with two groups; one is administered with the well-known substance in Japan, metformin (also known as the drug in the biguanide class) and the other group is the control group. The results will be used for better selection of patients to use the drug, and will be used to prevent any complication that may be caused by the drug.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amount of change in FMD at 16 weeks from baseline
Key secondary outcomes	Amount of change in FMD, CAVI, IMT, and Bio Marker at 52 weeks from baseline

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A group of add-on Linagliptin
Interventions/Control_2	A group of titration up Metformin
Interventions/Control_3	A group of control
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Only those meet the following criteria will be qualified for this study 1. (only the type II diabetic patient) in addition to diet and physical therapy, 1) taking metformin 750mg for 12+ weeks, Or 2) taking Metformin 750mg, plus use of oral hypoglycemic agent for 12+ week. However only limit to the patients who take SU drug 2mg or less, and glimicron 40mg or less 2. HbA1c 6.0% ~ 8.0% or less 3. 20+ years old 4. patients who are willing to follow the instruction of drug intake 5. patients who provide their informed consent
Key exclusion criteria	Person who correspond to any of following are excluded: 1.Patients who have Diabetes Type I or diabetic condition induced by other disease 2. Patients who take drugs in the thiazolidinediones class or DPP4-inhibitors, or insulin and incretin used drugs within 12 weeks before signing their informed consent 3. Patients who take more than 750mg of metformin on the day of signing their informed consent 4.Patients who started to use ACEI,ARB, statin or antiplatelet drug 5.Patients who are severe infectious disease, perioperative, and severe trauma 6.Patients with myocardial infarction, angina pectoris, cerebral stroke, or cerebral infarction within 12 weeks before signing their informed consent 7.Patients with atrial fibrillation frequent ventricular ectopy or PVC 8.Patients with moderate or severer heart failure (NYHA/New York Heart Association stage III or severer) 9.ABI,under 0.9 10.Patients with severe liver dysfunction or compromised renal function 11.Patients with labile hypertension or labile hyperlipidaemia 12.Patients with alcohol or drug dependence 13.Patients who are pregnant, lactating, and possibly pregnant women and those planning to become pregnant 14.Patients with a history of hypersensitivity to investigational drugs 15.Patients with Systolic Blood Pressure,150mmHg over 16.Patients whom doctor judges as ineligible to this study
Target sample size	96

Research contact person
Name of lead principal investigator	Takahisa Hirose
Organization	Toho University Omori Medical Center
Division name	Division of Diabetes, Metabolism and Endcrinology
Address	6-11-1,Omori-Nishi,Ota-ku,Tokyo,Japan
TEL	03-3762-4151
Email	takahisa.hirose@med.toho-u.ac.jp

Public contact
Name of contact person	Hiroki Takayama
Organization	Soiken Inc.
Division name	Division of Clinical Study Support
Address	1-3-1 4F,Kanda-Ogawa machi,Chiyoda-ku,Tokyo,Japan
TEL	03-3295-1350
Homepage URL
Email	takayama@soiken.com

Sponsor
Institute	Japan society for Patient Reported Outcom
Institute
Department

Funding Source
Organization	Nippon boehringer-ingelheim Co.,Ltd
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 01 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 21 Day
Anticipated trial start date	2014 Year 02 Month 14 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 01 Month 07 Day
Last modified on	2017 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014932