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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012783
Receipt No. R000014932
Scientific Title The Randomized study of Linagliptin effectiveness for Endothelial function by using FMD
Date of disclosure of the study information 2014/01/08
Last modified on 2017/07/11

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Basic information
Public title The Randomized study of Linagliptin effectiveness for Endothelial function by using FMD
Acronym Relief study
Scientific Title The Randomized study of Linagliptin effectiveness for Endothelial function by using FMD
Scientific Title:Acronym 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
1st name
Middle name
Last name Takahisa Hirose
Organization Toho University Omori Medical Center
Division name Division of Diabetes, Metabolism and Endcrinology
Zip code
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
1st name
Middle name
Last name Hiroki Takayama
Organization Soiken Inc.
Division name Division of Clinical Study Support
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 08 Month 21 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000014932

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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