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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024316
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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