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

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

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000056962

Enrollment

300

Registered

2025-02-07

Start date

2025-01-23

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 tirzepatide between 4/18/2023 to 12/31/2024

Exclusion criteria

Exclusion criteria: 1) Subjects for whom administration of tirzepatide is contraindicated in the package insert (a history of hypersensitivity to the components of this drug, diabetic ketoacidosis, diabetic coma, 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 change in HbA1c before and after tirzepatide treatment 2) The safety of tirzepatide	—

Secondary

Measure	Time frame
1) The change in body weight 2) The changes in plasma glucose, systolic/diastolic blood pressure, lipid metabolism, liver function, kidney function, microalbuminuria and/or proteinuria after 6 months tirzepatide treatment 3) The changes in treatment for diabetes, dyslipidemia, and hypertension for 6 months tirzepatide treatment 4) Adverse events 5) Patient background 6) The factors associated with improvement of metabolic index 7) Effects of continuation or discontinuation of antihyperglycemic agents other than tirzepatide 8) Effects on metabolic parameters by patient background status, including by facility and with/without nutritional guidance 9) Effects of medications for the comorbidities on HbA1c and body weight after tirzepatide treatment	—

Measure

Time frame

1) The change in body weight 2) The changes in plasma glucose, systolic/diastolic blood pressure, lipid metabolism, liver function, kidney function, microalbuminuria and/or proteinuria after 6 months tirzepatide treatment 3) The changes in treatment for diabetes, dyslipidemia, and hypertension for 6 months tirzepatide treatment 4) Adverse events 5) Patient background 6) The factors associated with improvement of metabolic index 7) Effects of continuation or discontinuation of antihyperglycemic agents other than tirzepatide 8) Effects on metabolic parameters by patient background status, including by facility and with/without nutritional guidance 9) Effects of medications for the comorbidities on HbA1c and body weight after tirzepatide treatment

—

Countries

Japan

Contacts

Public ContactHiroshi Nomoto

Asahikawa Medical University Hospital Department of diabetology and endocrinology

hnomoto@asahikawa-med.ac.jp0166-65-2111

Outcome results