Study for the efficacy and safety of oral semaglutide in subjects with type 2 diabetes
Phase 4
Recruiting
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000050583
- Lead Sponsor
- Hokkaido University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
Not provided
Exclusion Criteria
1) Subjects for whom administration of oral semaglutide is contraindicated in the package insert (a history of hypersensitivity to the components of this drug, hyperglycemic emergencies such as diabetic ketoacidosis, severe infections) 2) Subjects who are inadequate to enter this study due to the other reasons by physician's judgments
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) The changes in HbA1c before and after semaglutide treatment 2) The safety of semaglutide especially regarding gastrointestinal symptoms and hypoglycemia
- Secondary Outcome Measures
Name Time Method 1) The change in body weight 2) The changes in plasma glucose, systolic/diastolic blood pressure, pulse rate, lipid metabolism, liver function, kidney function, proteinuria, and microalbuminuria after 6 months semaglutide treatment 3) The changes in drugs for diabetes, dyslipidemia, and hypertension after 6 months semaglutide treatment 4) Adverse effects 5) Patient background 6) The factors associated with improvement of HbA1c and body weight 7) Effects of continuation or discontinuation of anti-hyperglycemic agents other than semaglutide 8) Effects of medications for the comorbidities on body weight after semaglutide treatment