UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038160 |
|---|---|
| Receipt number | R000043499 |
| Scientific Title | Effects of pemafibrate on metabolic parameters in patients with diabetes |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2024/04/04 14:02:31 |
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Basic information
Public title
Effects of pemafibrate on metabolic parameters in patients with diabetes
Acronym
Effects of pemafibrate on metabolic parameters in patients with diabetes
Scientific Title
Effects of pemafibrate on metabolic parameters in patients with diabetes
Scientific Title:Acronym
Effects of pemafibrate on metabolic parameters in patients with diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes and hypertriglyceridemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effects of pemafibrate on glucose- and lipid-metabolic parameters in patients with type 2 diabetes and hypertriglyceridemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of serum triglyceride level every 1 month for 5 years
Key secondary outcomes
Measurement of serum levels of cholesterol, glucose, insulin, and hepatic function parameters, HbA1c level, and BMI every 1 month for 5 years
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
Pemafibrate (0.1 mg b.i.d.) was administered for 5 years
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes having hypertriglyceridemia
Key exclusion criteria
Patients having hepatic and renal dysfunction (serum levels of AST, ALT, and gamma-GTP >100 U/L and/or serum creatinine level >2.0 mg/dL)
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masataka |
| Middle name | |
| Last name | Kusunoki |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
464-8601
Address
Furo-cho, Chikusa-ku, Nagoya
TEL
+81-52-789-3946
info@tonyo.jp
Public contact
Name of contact person
| 1st name | Masataka |
| Middle name | |
| Last name | Kusunoki |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
464-8601
Address
Furo-cho, Chikusa-ku, Nagoya
TEL
+81-52-789-3946
Homepage URL
info@tonyo.jp
Sponsor or person
Institute
Akishima Clinic
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Akishima Clinic
Address
4-2-29, Sakae, Naka-ku, Nagoya
Tel
+81 52 243 1024
kusu0910noki@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人社団織田会あきしまクリニック
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.atherosclerosis-journal.com/article/S0021-9150(22)01050-4/fulltext
Number of participants that the trial has enrolled
27
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 08 | Month | 18 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 30 | Day |
Last modified on
| 2024 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043499
