Type 2 Diabetes
Conditions
Interventions
Group A
patients who take the addition of Linagliptin
Group B
patients who do not take the addition of Linagliptin
Sponsors
Japan society for Patient Reported Outcome
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with only one type insulin,or with the combination drug therapy of oral diabetic medicine,except DPP4 inhibitor and Alpha-GI more than 3 months. Also, patients who had not taken Incretin Formula, such as DPP-4 inhibitor, more than 12 weeks can enroll this study. No concern about the number of insulin shot per day. 2.Type 2 diabetic patients (HbA1c(NGSP value),higher than 7.0% but lower than 10.0%) 3.age,20-80 4.Written informed consent are taken for the enrollment
Exclusion criteria
Exclusion criteria: Person who correspond to any of following are excluded: 1.Patients who are Type I or Secondary diabetic mellitus 2.Patients who are treating with Insulin, more than 1 I.U/kg per day 3.Patients who are treating with two or more types of Insulin 4.Patients who are treating with CSII (Continuous Subcutaneous Insulin Infusion) 5.Patients who are treating with DPP-4 Inhibitor, GLP-1 and Alpha-GI at the time of study initiation 6.Patients who are severe infectious disease, perioperative, and severe trauma 7.Patients with myocardial infarction, angina pectoris, cerebral stroke, or cerebral infarction 8.Patients with severe liver dysfunction ( AST:100 IU/l or higher) 9.Patients with moderate or severer heart failure (NYHA/New York Heart Association stage 3 or severer) 10.Patients who require dialysis. 11.Patients who are pregnant, lactating, and possibly pregnant women and those planning to become pregnant 12.Patients with a history of hypersensitivity to investigational drugs. 13.Patients with cancer 14.Patients who receive steroid therapy with inflammatory affection 15.Patients whom doctor judges as ineligible to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of efficacy to glycemic control from baseline (Visit 0) to 16 weeks. Quantity change of HbA1c | — |
Countries
Japan
Contacts
Public Contacttakayama Hiroki
Soiken Inc. Division of Clinical Study Support
Outcome results
None listed