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

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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 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


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

Value
https://center6.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