UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053539 |
|---|---|
| Receipt number | R000061073 |
| Scientific Title | Effects of combined therapy of imeglimin and hypolipidemic agents on metabolic parameter in patients with type 2 diabetes |
| Date of disclosure of the study information | 2024/02/05 |
| Last modified on | 2024/09/02 16:19:39 |
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Basic information
Public title
Effects of combined therapy of imeglimin and hypolipidemic agents on metabolic parameter in patients with type 2 diabetes
Acronym
Effects of combined therapy of imeglimin and hypolipidemic agents on metabolic parameter in patients with type 2 diabetes
Scientific Title
Effects of combined therapy of imeglimin and hypolipidemic agents on metabolic parameter in patients with type 2 diabetes
Scientific Title:Acronym
Effects of combined therapy of imeglimin and hypolipidemic agents on metabolic parameter in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of combined treatment of imeglimin and hypolipidemic agents for 3 months on blood metabolic parameters in patients with type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight, serum lipids, and liver function marker
Key secondary outcomes
Hemoglobin A1c level
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The patients with type 2 diabetes are treated with imeglimin (2000 mg/day) and hypolipidemic agent (1-2 mg/day pitavastatin or 2.5-5 mg/day rosuvastatin) for 12 months
Interventions/Control_2
The patients with type 2 diabetes are treated with imeglimin (2000 mg/day) and hypolipidemic agent (200 mg/day bezafibrate, 160 mg/day fenofibrate, 0.2 mg/day pemafibrate, 2 g/day omega-3-acid ethyl esters, or 900 mg/day icosapentoic acid ethyl ester) for 12 months
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hemoglobin A1c level: 6.5-11.5%
Key exclusion criteria
eGFR: less than 45 mL/min/1.73m2
Target sample size
100
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
052-789-3946
kusunoki@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
052-789-3946
Homepage URL
kusunoki@tonyo.jp
Sponsor or person
Institute
Akishima Clinic
Institute
Department
Personal name
Funding Source
Organization
Akishima Clinic
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
052-243-1024
info@tonyo.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（愛知県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 05 | 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
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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 04 | Day |
Last modified on
| 2024 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061073
