UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010534 |
|---|---|
| Receipt number | 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 | 2024/07/03 13:42:40 |
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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 | HIROTAKA |
| Middle name | |
| Last name | WATADA |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Medicine, Metabolism and Endocrinology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
hwatada@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Watada |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Medicine, Metabolism and Endocrinology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
hwatada@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
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
Research Ethics Committee, Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1589
chiken@juntendo.ac.jp
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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
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
| 2024 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012293
