Study for the efficacy and safety of oral semaglutide in subjects with type 2 diabetes

Study for the efficacy and safety of oral semaglutide in subjects with type 2 diabetes -retrospective observation trial - Study for the usefulness and safety of oral semaglutide

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050583

Enrollment

500

Registered

2023-03-14

Start date

2022-10-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects with type 2 diabetes who were newly treated with oral-semaglutide between 2/5/2021 to 12/31/2022

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1) The changes in HbA1c before and after semaglutide treatment 2) The safety of semaglutide especially regarding gastrointestinal symptoms and hypoglycemia	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactHiroshi Nomoto

Hokkaido University Hospital Department of diabetology and endocrinology

hnomoto@med.hokudai.ac.jp011-706-5915

Outcome results