Type 2 diabetes
Conditions
Interventions
Alogliptin treatment group (Group A)
Clinical investigators will initiate alogliptin treatment following the allocation in the alogliptin treatment group. Treatment will be continued to achieve the target value specified in the diabetes
Clinical investigators will continue conventional treatment using drugs other than the DPP-4 inhibitor in the conventional treatment group. Treatment will be continued to achieve the target value spec
Sponsors
Juntendo University Graduate School of Medicine
Osaka University Graduate School of Medicine
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 |
|---|---|
| Changes in the IMT value (mean and max IMT) during a 24-month treatment period measured by carotid arterial echography | — |
Countries
Japan
Contacts
Public ContactTomoya Mita
Juntendo University Graduate School of Medicine Department of Medicine, Metabolism and Endocrinology
Outcome results
None listed