Diabetes
Conditions
Interventions
Administration of exenatide first, then change to sitagliptin (for 12 weeks each)
Administration of sitagliptin first, then change to exenatide (for 12 weeks each)
Sponsors
Tokorozawa Heart Center
Self-Defense Forces Fuji Hospital National defense medical college hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diabetic patients whose HbA1c levels are greater than 7, despite medical therapy including life style change/medications for at least 8 weeks 2) 20 years of age or older and 75 years of age or younger. 3) Female or Male 4) Outpatients 5) Subjects who gave written informed consent
Exclusion criteria
Exclusion criteria: Allergy against exenatide /sitagliptin 2) Type I diabetes 3) Secondary diabetes 4) Poor-controlled diabetes (HbA1c>10.0 %) 5) Subjects who takes GLP-1 receptor agonist or DPP4 inhibitor. 6)History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 7) Either level of aspartate aminotransaminase or alanine aminotransferase exceed three-fold of the normal limits 8) renal insufficiency: serum creatinine>1.3 (male)>1.2(female) 9) Symptomatic (NYHA III or IV) congestive heart failure 10) Malignancies or other diseases with poor prognosis 11) Pregnant 12) Subjects whose doctor in charge do not agree to join the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1C levels, glycoalbumin levels, blood glucose/lipids levels, and flow-mediated vasodilation in forearm Twelve 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) Twelve weeks after administration | — |
Countries
Japan
Contacts
Public ContactMisa Ito
Self-Defense Forces Fuji Hospital Department of Internal Medicine
Outcome results
None listed