UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Naoyuki Kamatani
Organization	Tsukuba International Clinical Pharmacology Clinic
Division name	Doctors' office
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	Masanori Suzuki
Organization	Tsukuba International Clinical Pharmacology Clinic
Division name	Division for Volunteers
Address	1-21-16 Kan-nondai Tsukuba City, Ibaraki Prefecture
TEL	029-839-1150
Homepage URL
Email	m-suzuki@tsukuba-icp.jp

Sponsor
Institute	Tsukuba International Clinical Pharmacology Clinic
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028008