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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007396
Receipt No. R000008717
Scientific Title Sitagliptin Prospective study of Intima media thickness Evaluation
Date of disclosure of the study information 2012/02/28
Last modified on 2016/03/07

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

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is 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 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

Eligibility
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

Research contact person
Last 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

Public contact
1st 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

Sponsor
Institute Japan society for Patient Reported Outcome
Institute
Department

Funding Source
Organization Japan society for Patient Reported Outcome
Organization
Division
Category of Funding Organization Self funding
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 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)

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 28 Day

Related information
URL releasing protocol http://care.diabetesjournals.org/content/39/3/455.long
Publication of results Published

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
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
Other related information

Management information
Registered date
2012 Year 02 Month 28 Day
Last modified on
2016 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008717

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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