UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063326 |
|---|---|
| Receipt number | R000070148 |
| Scientific Title | Real-world effectiveness and safety of subcutaneous tirzepatide in patients with type 2 diabetes mellitus |
| Date of disclosure of the study information | 2026/10/20 |
| Last modified on | 2026/10/17 20:53:00 |
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Basic information
Public title
A study to evaluate the effectiveness and safety of tirzepatide injection in patients with type 2 diabetes
Acronym
Tirzepatide Study for Type 2 Diabetes
Scientific Title
Real-world effectiveness and safety of subcutaneous tirzepatide in patients with type 2 diabetes mellitus
Scientific Title:Acronym
TIRZE-T2D Study
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effectiveness and safety of subcutaneous tirzepatide in patients with type 2 diabetes mellitus in clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c from baseline to 12 months after initiation of tirzepatide therapy
Key secondary outcomes
Changes in body weight and BMI
Changes in liver enzymes (AST, ALT),(ATI,SWE)
Changes in renal function (eGFR)
Changes in lipid profile (LDL-C, HDL-C, triglycerides)
Changes in urinary albumin excretion (ACR)
Changes in body composition (fat mass, muscle mass)
Incidence of adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes mellitus treated at our institution
Patients who received subcutaneous tirzepatide
Patients with available clinical data before and after treatment initiation
Patients with at least 12 months of follow-up
Key exclusion criteria
Patients referred to other institutions and lost to follow-up
Patients who discontinued tirzepatide on their own
Patients who discontinued tirzepatide treatment
Patients with less than 12 months of follow-up
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Saori |
| Middle name | |
| Last name | Inoue |
Organization
Meitetsu hospital
Division name
Department of Endocrinology and Metabolism
Zip code
4510052
Address
2-26-11 Sako, Nishi-ku, Nagoya, Aichi, Japan
TEL
0570-023-100
little_tree3669@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Inoue |
Organization
Meitetsu Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
451-0052
Address
2-26-11 Sako, Nishi-ku, Nagoya, Aichi, Japan
TEL
0570023100
Homepage URL
saori7174914@gmail.com
Sponsor or person
Institute
Meitetsu hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Meitetsu Hospital
Address
2-26-11 Sako, Nishi-ku, Nagoya, Aichi, Japan
Tel
0570023100
jimubu_uketuke@meitetsu-hpt.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
295
Org. issuing International ID_1
Institutional Review Board, Meitetsu Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
名鉄病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 20 | Day |
Related information
URL releasing protocol
The study protocol is not publicly available.
Publication of results
Published
Result
URL related to results and publications
The study protocol is not publicly available.
Number of participants that the trial has enrolled
82
Results
HbA1c significantly decreased from 7.95% [6.55-9.05] to 6.3% [5.8-7.2] at 12 months after initiation of tirzepatide (p < 0.001). Body weight and BMI were also significantly reduced. Improvements were observed in liver enzymes (AST, ALT) and lipid profile (LDL-C, HDL-C, triglycerides). A slight change in renal function (eGFR) was noted. Gastrointestinal symptoms were the most common adverse events.
Results date posted
| 2026 | Year | 04 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 82 patients with type 2 diabetes mellitus were included in this study. The median age was 55 years [49-66.5], with 55 males and 27 females. Baseline HbA1c was 7.95% [6.55-9.05], and BMI was 29.5 kg/m2 [26.9-34.4]. The median duration of diabetes was 8 years [4-14], and eGFR was 72 mL/min/1.73 m2[57-88]. Many patients were receiving concomitant medications, including SGLT2 inhibitors and biguanides.
Participant flow
A total of 101 patients who received tirzepatide at our institution were initially identified. After excluding 3 patients referred to other institutions, 3 who discontinued treatment on their own, and 13 who discontinued treatment, 82 patients with at least 12 months of follow-up were included in the final analysis.
Adverse events
Gastrointestinal symptoms were observed in 8 patients. Other events included weight loss (n = 1), treatment discontinuation due to financial reasons (n = 1), and refusal of injection (n = 1). Serious adverse events requiring hospitalization included cerebral infarction (n = 1), cholelithiasis (n = 1), osteomyelitis (n = 1), and nausea (n = 1).
Outcome measures
The primary outcome was the change in HbA1c from baseline to 12 months after initiation of tirzepatide. Secondary outcomes included changes in body weight and BMI, liver enzymes (AST, ALT), renal function (eGFR), lipid profile (LDL-C, HDL-C, triglycerides), urinary albumin excretion (ACR), body composition (fat mass, muscle mass), incidence of adverse events, as well as changes in liver stiffness assessed by shear wave elastography (SWE) and hepatic steatosis assessed by attenuation imaging (ATI).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2026 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2026 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2026 | Year | 04 | Month | 01 | Day |
Other
Other related information
None.
Management information
Registered date
| 2026 | Year | 10 | Month | 17 | Day |
Last modified on
| 2026 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070148
