UMIN-CTR Clinical Trial

Public title

Sitagliptin Prospective study of Intima media thickness Evaluation

Acronym

Sitagliptin Prospective study of Intima media thickness Evaluation

Scientific Title

Sitagliptin Prospective study of Intima media thickness Evaluation

Scientific Title:Acronym

Sitagliptin Prospective study of Intima media thickness Evaluation

Region

Japan

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effects of hypoglycemic therapy with sitagliptin on arteriosclerosis progression by comparing a group receiving conventional treatment without DPP-4 inhibitor (C group) with a group receiving combination with DPP-4 inhibitor, i.e., sitagliptin (S group) in clinical practice in patients with type 2 diabetes who are using insulin. Intima-media thickness (IMT) of the carotid arteries, i.e., a surrogate marker for cardiovascular events, is measured to compare the inhibitory effects on arteriosclerosis progression. In addition, the effects on cardiovascular function and blood biomarkers as well as patients' psychological attitude toward the drug are to be studied.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Changes in the IMT value (mean and max IMT) during a 104-week treatment period measured by carotid arterial echography

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is 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

Sitagliptin treatment group (Group S);
Clinical investigators will initiate alogliptin treatment.

Interventions/Control_2

Control group (Group C);
Clinical investigators will continue conventional treatment using drugs other than the DPP-4 inhibitor and GLP-1 in the conventional treatment group.

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

30

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Patients with type 2 diabetes (HbA1c [JDS value] of 6.6% or above) who do not show achievement of the target for glycemic control defined in the "Treatment Guide for Diabetes 2010" despite the three or more months of insulin therapy* (one to four injections per day during treatment with rapid-acting, ultra-rapid-acting, long-acting, intermediate-acting, or mixed insulin) or insulin therapy combined with oral diabetic agents other than DPP-4 inhibitors. Those who had previously used DPP-4 inhibitors but have not taken them for the recent twelve or more weeks are also included.
2) Patients aged 30 or older and less than 80 years (males and females)
3) Patients who have provided written consent to participate in the study
* Except for CSII

Key exclusion criteria

1) Patients with type 1 or secondary diabetes
2) Patients with severe infections, pre-/post-operative status, and serious injuries
3) Patients with previous events of myocardial infarction, angina pectoris, stroke, or cerebral infarction
4) Patients complicated with diabetic retinopathy requiring retinal photocoagulation or crystalline lens surgery, or those who have undergone these treatments within the last one year
5) Patients with moderate or more severe renal dysfunction
(serum creatinine [mg/dL] > 1.4 [male] or > 1.2 [female])
6) Patients with severe liver dysfunction (AST: 100 IU/l or above)
7) Patients with moderate or more severe heart failure
(NYHA [New York Heart Association] class of III or above)
8) Patients prescribed other incretin-based agents, including DPP-4 inhibitors, at study initiation
9) Patients taking diabetic medicines, etc., that are prohibited for combination with incretin-based agents including DPP-4 inhibitors, by health insurance, at study initiation
10) Patients who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant
11) Patients with previous hypersensitivity to the investigated drug
12) Other patients determined ineligible by an investigator

Target sample size

274

Name of lead principal investigator

1st name
Middle name
Last name	HIROTAKA WATADA

Organization

Juntendo University Graduate School of Medicine

Division name

Department of Medicine, Metabolism and Endocrinology

Zip code

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo

TEL

Email

Name of contact person

1st name
Middle name
Last name	TOMOYA MITA

Organization

Juntendo University Graduate School of Medicine

Division name

Department of Medicine, Metabolism and Endocrinology

Zip code

Address

TEL

Homepage URL

Email

Institute

Japan society for Patient Reported Outcome

Institute

Department

Personal name

Organization

Japan society for Patient Reported Outcome

Organization

Division

Category of Funding Organization

Self funding

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

横山内科クリニック　（責任者：横山　宏樹）
那珂記念クリニック 　（責任者：遅野井　健）
順天堂大学附属江東高齢者病院　（責任者：小沼　富男）
順天堂大学附属順天堂医院　（責任者：三田　智也）
三咲内科クリニック 　（責任者：栗林　伸一）
大阪大学医学部附属病院　（責任者：金藤　秀明、片上　直人）
大阪警察病院　（責任者：小杉　圭右）
大阪府立急性期・総合医療センター （責任者：馬屋原　豊）
関西ろうさい病院（責任者：山本　恒彦）
日本生命済生会附属 日生病院　（責任者：笠山　宗正）
白岩内科医院　（責任者：白岩 俊彦）
佐世保中央病院　（責任者：松本　一成）

Date of disclosure of the study information

2012

Year

02

Month

28

Day

URL releasing protocol

http://care.diabetesjournals.org/content/39/3/455.long

Publication of results

Published

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

2012

Year

02

Month

21

Day

Date of IRB

Anticipated trial start date

2012

Year

02

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

2012

Year

02

Month

28

Day

Last modified on

2016

Year

03

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008717