UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024316
Receipt number R000028008
Scientific Title Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with glucose intolerance, and changes of blood and urine purine compounds.
Date of disclosure of the study information 2017/08/31
Last modified on 2017/05/09 13:21:41

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Basic information

Public title

Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with glucose intolerance, and changes of blood and urine purine compounds.

Acronym

Effect of febuxostat and inosine on glucose intolerance

Scientific Title

Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with glucose intolerance, and changes of blood and urine purine compounds.

Scientific Title:Acronym

Effect of febuxostat and inosine on glucose intolerance

Region

Japan


Condition

Condition

glucose intolerance

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examination of efficacy and safety of the combined use of febuxostat and inosine for subjects with glucose intolerance, and changes of blood and urine purine compounds.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Difference of blood glucose at 2 hours of glucose intolerance test between before and after the administration of febuxostat and inosine for 2 weeks

Key secondary outcomes



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

Administration of febuxostat 20 mg and inosine 0.5 g twice a day for 2 weeks

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

60 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Japanese male adult who showed HbA1c of not lower than 6.5%, fasting blood glucose of not lower than 126 mg/dL, casual blood glucose of not lower than 200 mg/dL or abnormal glucose tolerance judged by glucose tolerance test during the latest 6 months.
2. Subject with the ability to express his consent who, after a full explanation of the objective and contents of the present clinical study, has voluntarily expressed his consent to participate in the present clinical study.
3. Japanese with 20 to 60 years of age
4. Subject with BMI of not lower than 17.6 and lower than 28.0 on the day of screening test.

Key exclusion criteria

1. Routine user of medicine or supplement.
2. Subject who is currently being treated for diabetes.
3. Subject who has or had renal function disorder.
4. Subject with a history of gout, hyperuricemia or urolithiasis.
5. Subject who has a history of renal disorder.
6. Subject who has or had hypersensitivity, idiosyncracy (allergy) to drug.
7. Subjects taking azathioprine, mercaptopurine or other purine analogs
8. Subject with a disease or a disorder in heart, kidney, pulmonary organ, digestive organ or blood function that are considered to affect absorption, distribution, metabolism or excretion of a drug.
9. Subject who participated in another clinical study for a drug with a new compound within 4 weeks before the administration of drug in the present study.
10. Subject who donated 400 mL of blood within 12 weeks, 200 mL of blood within 4 weeks or blood components within 2 weeks.
11. Subject who used other drugs (including herbs) or supplements within 2 weeks before the administration of drug in this study.
12. Sujbect who plans to take other drugs (including herbs) or supplements before the end of the present study.
13. Subject who was judged not to be appropriate by the principal investigator or sub investigators by other reasons.

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoyuki Kamatani

Organization

Tsukuba International Clinical Pharmacology Clinic

Division name

Doctors' office

Zip code


Address

1-21-16 Kan-nondai Tsukuba City, Ibaraki Prefecture

TEL

029-839-1150

Email

kamatani@msb.biglobe.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masanori Suzuki

Organization

Tsukuba International Clinical Pharmacology Clinic

Division name

Division for Volunteers

Zip code


Address

1-21-16 Kan-nondai Tsukuba City, Ibaraki Prefecture

TEL

029-839-1150

Homepage URL


Email

m-suzuki@tsukuba-icp.jp


Sponsor or person

Institute

Tsukuba International Clinical Pharmacology Clinic

Institute

Department

Personal name



Funding Source

Organization

StaGen Co. LTD

Organization

Division

Category of Funding Organization

Profit 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

2017 Year 08 Month 31 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

Completed

Date of protocol fixation

2016 Year 08 Month 03 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 26 Day

Last follow-up date

2016 Year 11 Month 24 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 10 Month 06 Day

Last modified on

2017 Year 05 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028008


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name