Diabetes
Conditions
Interventions
Administration of sitagliptin first, then change to voglibose
Administration of voglibose first, then change to sitagliptin
Sponsors
National Defense Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) diabetic patients whose HbA1c is greater than 5.8, fasting blood glucose levels greater than 110mg/dl, or postprandial glucose levels grater than 180mg/dl, despite of medical therapy including life style change/medications for at least 8 weeks 2) Outpatients 3) Subjects who gave written informed consent
Exclusion criteria
Exclusion criteria: 1) Allergy against sitagliptin/voglibose 2) type I diabetes 3) secondary diabetes 4) Poor-controlled diabetes (HbA1c>10.0 %) 4) Secondary hypertension 5) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 6) Either level of aspartate aminotransaminase or alanine aminotransferase exceed three-fold of the normal limits 7) renal insufficiency: serum creatinine>1.3 (male)>1.2(female) 8) Symptomatic (NYHA III or IV) congestive heart failure 9) Malignancies or other diseases with poor prognosis 10) Pregnant 11) Subjects whose doctor in charge do not agree to join the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1C levels, glycoalbumin levels, pre/postprandial blood glucose/lipids levels, and Flow-mediated vasodilation in forearm Six weeks after administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria) Six weeks after administration | — |
Countries
Japan
Contacts
Public ContactMakoto Ayaori
National Defense Medical College Department of Internal Medicine I
Outcome results
None listed