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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010534
Receipt No. R000012293
Scientific Title Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis - Extension Study -
Date of disclosure of the study information 2013/04/18
Last modified on 2018/04/23

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Basic information
Public title Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis
- Extension Study -
Acronym SPEAD-A Extension
Scientific Title Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis
- Extension Study -
Scientific Title:Acronym SPEAD-A Extension
Region
Japan

Condition
Condition type2 Diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 SPEAD-A is ongoing clinical study how the glucose-lowering therapy with the group of DPP-4 inhibitor (Alogliptin benzoate) affect the progression of the arteriosclerosis, and it is compared with non DPP-4 inhibitor group.

The reason why we extend the duration of this study to 8 years more is that we can investigate the prognosis of the therapy with DPP-4 inhibitor based on the longer patient observation, especially we can research how the therapy affect the development of the event such as death of any cause, acute myocardial infarction, and any cerebrovascular accident.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the influence to the incident of the event (death of any cause, acute myocardial infarction, and any cerebrovascular accident) due to use of Alogliptin during the period of this clinical study.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Type 2 diabetes patients (HbA1c (JDS value) higher then 5.8% and below 9.0%) in whom the target of blood glucose control specified in the 2010 diabetes treatment guidelines is not achieved despite dietary/exercise therapy or those with concomitant therapeutic drugs for diabetes other than a DPP-4 inhibitor being performed for 3 months or longer, including those after a 12-week or longer withdrawal of previous DPP-4 inhibitor treatment.
2) Thirty years of age or older (regardless of gender)
3) Written consent for participation in the study
Key exclusion criteria Patients meeting one of the following conditions will be excluded:
1) Type I and secondary diabetes
2) Severe infectious disease, before or after surgery, and severe trauma
3) Events of myocardial infarction, angina pectoris, cerebral stroke, and cerebral infarction
4) Moderate renal dysfunction
(Serum creatinine (mg/dL): male, 1.4<; female, 1.2<)
5) Severe liver dysfunction (AST: 100 IU/l or higher)
6) Moderate or severer heart failure)
(NYHA/New York Heart Association stage III or severer)
7) Under treatment with an incretin preparation, such as other DPP-4 inhibitors, at the time of study initiation
8) Under insulin treatment
9) Under treatment with therapeutic drugs not concomitantly administrable with incretin preparations, such as DPP-4 inhibitors, with regard to national health insurance, at the time of study initiation
10) Pregnant, lactating, and possibly pregnant women and those planning to become pregnant
11) Past medical history of hypersensitivity to investigational drugs
12) Judged as ineligible by clinical investigators
Target sample size 324

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
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Juntendo University Graduate School of Medicine
Division name Department of Medicine, Metabolism and Endocrinology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Juntendo University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 18 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
2013 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 22 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 influence to the incident of the event annually (death of any cause, acute myocardial infarction, and any cerebrovascular accident) due to use of Alogliptin during the period of this clinical study.

Management information
Registered date
2013 Year 04 Month 18 Day
Last modified on
2018 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012293

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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