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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017926
Receipt No. 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

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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
Email 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
Email ts2281@kumamoto-u.ac.jp

Sponsor
Institute Dept. of Molecular Physiology and Metabolic Medicine,
Faculty of Life Sciences,
Kumamoto University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020719

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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