UMIN-CTR Clinical Trial

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

Type 2 Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Japan society for Patient Reported Outcom

Institute

Department

Personal name

Organization

Nippon boehringer-ingelheim Co.,Ltd

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

01

Month

08

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

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 related information

Registered date

2014

Year

01

Month

07

Day

Last modified on

2017

Year

07

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014932