UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056862 |
|---|---|
| Receipt number | R000064977 |
| Scientific Title | Investigation of the effects of tirzepatide (Mounjaro) |
| Date of disclosure of the study information | 2025/01/29 |
| Last modified on | 2025/07/01 12:17:23 |
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Basic information
Public title
Investigation of the effects of tirzepatide (Mounjaro)
Acronym
Investigation of the effects of tirzepatide (Mounjaro)
Scientific Title
Investigation of the effects of tirzepatide (Mounjaro)
Scientific Title:Acronym
Investigation of the effects of tirzepatide (Mounjaro)
Region
| Japan |
Condition
Condition
type2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of tirzepatide on insulin sensitivity in type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in glucose infusion required rate in the hyperinsulinemic-euglycemic clamp analysis from baseline to 12 weeks after the start of tirzepatide
Key secondary outcomes
changes in HbA1c, fasting plasma glucose, body weight, body composition (muscle mass, fat mass, fat percentage), fasting lipid profile (triglycerides, HDL cholesterol, LDL cholesterol), fasting glucagon levels, HOMA2-IR, HOMA2-%be-ta, and the correlations between the changes of these measurements and glucose infusion required rate.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administrate tirzepatide starting at a dose of 2.5 mg once weekly, the dose being increased to 5 mg after four weeks and maintained until the study endpoint at 12 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) type2 diabetes
2) baseline HbA1c level < 12.0%
3) BMI >=25 kg/m2
4) with or without metformin monotherapy at a stable dose
Key exclusion criteria
(i) diagnosis of type 1 diabetes or other type of diabetes,
(ii) hypoglycemic agent other than metformin,
(iii) medication or disease affecting glycemic management or body composition (corticosteroids, thyroid disease, malignancy, etc.),
(iv) hospitalization within the observation period,
(v) severe liver dysfunction (serum aspartate aminotransferase or alanine aminotransferase level >=2 times the normal upper limit),
(vi) renal dysfunction (estimated glomerular filtration rate of <45 mL/min/1.73 m2),
(vii) severe cardiac dysfunction (New York Heart Association class>II),
(viii) judgment by the researchers for any other reason of ineligibility to participate
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kuwata |
Organization
Kansai Electric Power Hospital
Division name
Center for Diabetes, Endocrinology and Metabolis
Zip code
553-0003
Address
2-1-7 Fukushima, Fukushima-ku, Osaka-shi, Osaka, Japan
TEL
+81-6-6458-5821
kuwata-kob@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kuwata |
Organization
Kansai Electric Power Hospital
Division name
Center for Diabetes, Endocrinology and Metabolis
Zip code
553-0003
Address
2-1-7 Fukushima, Fukushima-ku, Osaka-shi, Osaka, Japan
TEL
+81-6-6458-5821
Homepage URL
kuwata-kob@umin.ac.jp
Sponsor or person
Institute
Kansai Electric Power Hospital
Institute
Department
Personal name
Hitoshi Kuwata
Funding Source
Organization
Center for Diabetes, Endocrinology and Metabolism, Kansai Electric Power Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Electric Power Hospital
Address
2-1-7 Fukushima, Fukushima-ku, Osaka-shi, Osaka, Japan
Tel
+81-6-6458-5821
kuwata-kob@umin.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
24-055
Org. issuing International ID_1
Ethics Committee of Kansai Electric Power Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
16
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 29 | Day |
Last modified on
| 2025 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064977
