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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014014
Receipt No. R000016322
Scientific Title Sitagliptin Prospective study of Intima media thickness Evaluation Extension Study
Date of disclosure of the study information 2014/05/20
Last modified on 2016/05/20

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Basic information
Public title Sitagliptin Prospective study of Intima media thickness Evaluation Extension Study
Acronym SPIKE Extension Study
Scientific Title Sitagliptin Prospective study of Intima media thickness Evaluation Extension Study
Scientific Title:Acronym SPIKE Extension Study
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 a Dipeptidyl-Peptidase 4 (DPP-4) inhibitor sitagliptin for the risk of cardiovascular events, especially on, mortality ,
acute myocardial infarction and cerebral infarction by extending SPIKE study for 8 years.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of cardiovascular event rates (e.g. death, acute myocardial infarction, and cerebral infarction), and correlation between the use of sitagliptin and the events
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
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 03-3813-3111
Email hwatada@juntendo.ac.jp

Public contact
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 2-1-1 Hongo,Bunkyo-ku,Tokyo
TEL 03-3813-3111
Homepage URL
Email tom-m@juntendo.ac.jp

Sponsor
Institute Japan Cardiovascular Research foundation
Institute
Department

Funding Source
Organization Japan Cardiovascular Research foundation
Organization
Division
Category of Funding Organization Non profit foundation
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 05 Month 20 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 No longer recruiting
Date of protocol fixation
2014 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate the effects of hypoglycemic therapy with sitagliptin for risk of cardiovascular event, especially death, acute myocardial infarction and cerebral infarction, by 8 years extension of spike study .
Observed point is once a year.

Management information
Registered date
2014 Year 05 Month 20 Day
Last modified on
2016 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016322

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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