Type 2 Diabetes
Conditions
Interventions
A group of add-on Linagliptin
A group of titration up Metformin
A group of control
Sponsors
Japan society for Patient Reported Outcom
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only those meet the following criteria will be qualified for this study 1. (only the type II diabetic patient) in addition to diet and physical therapy, 1) taking metformin 750mg for 12+ weeks, Or 2) taking Metformin 750mg, plus use of oral hypoglycemic agent for 12+ week. However only limit to the patients who take SU drug 2mg or less, and glimicron 40mg or less 2. HbA1c 6.0% ~ 8.0% or less 3. 20+ years old 4. patients who are willing to follow the instruction of drug intake 5. patients who provide their informed consent
Exclusion criteria
Exclusion criteria: Person who correspond to any of following are excluded: 1.Patients who have Diabetes Type I or diabetic condition induced by other disease 2. Patients who take drugs in the thiazolidinediones class or DPP4-inhibitors, or insulin and incretin used drugs within 12 weeks before signing their informed consent 3. Patients who take more than 750mg of metformin on the day of signing their informed consent 4.Patients who started to use ACEI,ARB, statin or antiplatelet drug 5.Patients who are severe infectious disease, perioperative, and severe trauma 6.Patients with myocardial infarction, angina pectoris, cerebral stroke, or cerebral infarction within 12 weeks before signing their informed consent 7.Patients with atrial fibrillation frequent ventricular ectopy or PVC 8.Patients with moderate or severer heart failure (NYHA/New York Heart Association stage III or severer) 9.ABI,under 0.9 10.Patients with severe liver dysfunction or compromised renal function 11.Patients with labile hypertension or labile hyperlipidaemia 12.Patients with alcohol or drug dependence 13.Patients who are pregnant, lactating, and possibly pregnant women and those planning to become pregnant 14.Patients with a history of hypersensitivity to investigational drugs 15.Patients with Systolic Blood Pressure,150mmHg over 16.Patients whom doctor judges as ineligible to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of change in FMD at 16 weeks from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Amount of change in FMD, CAVI, IMT, and Bio Marker at 52 weeks from baseline | — |
Countries
Japan
Contacts
Public ContactHiroki Takayama
Soiken Inc. Division of Clinical Study Support
Outcome results
None listed