Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis - Extension Study -

Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis - Extension Study - - SPEAD-A Extension

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000010534

Enrollment

324

Registered

2013-04-18

Start date

2013-04-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type2 Diabetes

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactHirotaka Watada

Juntendo University Graduate School of Medicine Department of Medicine, Metabolism and Endocrinology

hwatada@juntendo.ac.jp03-3813-3111

Outcome results