UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017926 |
|---|---|
| Receipt number | R000020719 |
| Scientific Title | Clinical study for companion diagnostics for type 2 diabetes (T2DM) with aberrant tRNA modification. |
| Date of disclosure of the study information | 2015/06/17 |
| Last modified on | 2017/05/11 17:40:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical study for companion diagnostics for type 2 diabetes (T2DM) with aberrant tRNA modification.
Acronym
Clinical study for companion diagnostics for type 2 diabetes (T2DM) with aberrant tRNA modification.
Scientific Title
Clinical study for companion diagnostics for type 2 diabetes (T2DM) with aberrant tRNA modification.
Scientific Title:Acronym
Clinical study for companion diagnostics for type 2 diabetes (T2DM) with aberrant tRNA modification.
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of the study is to compare the efficacy of Eperisone to decrease HbA1c in T2DM patients carrying between non-risk and risk alleles of CDKAL1, and to examine the correlation between thiomethyl modification at A37 of tRNALys(UUU) and the improvement effect of Eperisone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of Eperizone in HbA1c changes from baseline between risk and non-risk allele groups.
Key secondary outcomes
1) Correlation between thiomethyl modification at A37 of tRNALys(UUU) and change in HbA1c.
2) Comparison between two groups in the folloblood glucose controlwing parameters at 12 weeks.
3) Index for blood glucose control (FBG, 1,5-AG).
4) Beta cell functions (Glucagon tolerance test, HOMA-B, proinsulin/insulin ratio)
5) Parameters for lipid metabolism (Total cholesterol, LDL-Chol, HDL-Chol, TG)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1) Cdkal1 homo risk allele
Eperisone (50 mg tablet), 1 Tab. po, TID for 12 weeks.
Interventions/Control_2
2) Cdkal1 hetero non-risk allele
Eperisone (50 mg tablet), 1 Tab. po, TID for 12 weeks.
Interventions/Control_3
3) Homo non-risk allele
Eperisone (50 mg tablet), 1 Tab. po, TID for 12 weeks.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with type 2 diabetes.
2) Age 20 - 75 y.o.
3) Type 2 diabetes patients with mono or combination therapy of following OHA - SU, Glinides, a-GI, Biguanides, Thiazolidinedione, or DPP-4 inhibitors.
4) HbA1c 6.2 - 8.5%
5) HbA1c change <= 1.0% with no alteration of treatment for 3 months prior to the day of screening.
6) Females who sign for contraception, if capable of pregnancy.
7) Patients with adequate understanding and/or cooperation as judged by the Investigator
8) Patients with written informed consent.
Key exclusion criteria
1) Recurrent severe hypoglycaemia or hypoglycaemic unawareness.
2) Liver dysfunction (AST => 100 IU/L, ALT => 100 IU/L)
3) Previous history of severe allergy to pharmaceutical products.
4) Pregnancy
5) Mental incapacity (including moderate or severe dementia) precluding adequate understanding and/or cooperation as judged by the Investigator.
6) Hospitalization.
7) Treatment with prohibited drugs.
8) Prescription of Eperison within 4 weeks.
9) Patients who is taking Methocarbamol.
10) Participant of other clinical study at the screening.
11) Any condition that the investigator considers a potential obstacle to trial participation and/or data analysis.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhito Tomizawa |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Dept. of Molecular Physiology
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
TEL
096-373-5050
tomikt@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takafumi Senokuchi |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Molecular Diabetology
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
TEL
096-373-5169
Homepage URL
ts2281@kumamoto-u.ac.jp
Sponsor or person
Institute
Dept. of Molecular Physiology and Metabolic Medicine,
Faculty of Life Sciences,
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 17 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 22 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 26 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 16 | Day |
Last modified on
| 2017 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020719
