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 2023/05/02 12:13:38

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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 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


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

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

2023 Year 05 Month 02 Day



Link to view the page

Value
https://center6.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